A nurse‐led education and cognitive behaviour therapy‐based intervention among adults with uncontrolled type 2 diabetes: A randomised controlled trial

OR I G I N A L A R T I C L E

A nurse‐led education and cognitive behaviour therapy‐based intervention among adults with uncontrolled type 2 diabetes: A randomised controlled trial

Lisa C. Whitehead PhD1 | Marie T. Crowe PhD2 | Janet D. Carter PhD3 |

Virginia R. Maskill MHealSc4 | Dave Carlyle PhD5 | Carol Bugge PhD6 |

Chris M. A. Frampton PhD7

1Associate Dean Research, School of Nursing

and Midwifery, Edith Cowan University,

Joondalup, Australia

2Associate Dean, Centre for Postgraduate

Nursing Studies & Department of

Psychological Medicine, University of Otago,

Christchurch, New Zealand

3Head of Department, Department of

Psychology, University of Canterbury,

Christchurch, New Zealand

4Lecturer, Centre for Postgraduate Nursing

Studies, University of Otago, Christchurch,

New Zealand

5Senior Lecturer, School of Health Sciences,

University of Otago, Christchurch, New

Zealand

6Senior Lecturer, School of Health Sciences,

University of Stirling, Stirling, UK

7Biostatistician, Department of Psychological

Medicine, University of Otago, Christchurch,

New Zealand

Correspondence

Lisa C. Whitehead, School of Nursing and

Midwifery, Edith Cowan University, 270

Joondalup Drive, Joondalup, Western

Australia, Australia.

Email: l.whitehead@ecu.edu.au

Abstract

Rationale, aims and objectives Diabetes mellitus is associated with significant morbidity,

mortality, and escalating health care costs. Research has consistently demonstrated the impor-

tance of glycaemic control in delaying the onset, and decreasing the incidence, of both the

short‐term and long‐term complications of diabetes. Although glycaemic control is difficult to

achieve and challenging to maintain, it is key to reducing negative disease outcomes.

The aim of this study was to determine whether a nurse‐led educational intervention alone or a

nurse‐led intervention using education and acceptance and commitment therapy (ACT) was

effective in reducing hemoglobin A1c (HbA1c) in people living with uncontrolled type 2 diabetes

compared to usual care.

Methods Adults over the age of 18 years, with a confirmed diagnosis of type 2 diabetes and

HbA1c outside of the recommended range (4%‐7%, 20‐53 mmol/mol) for 12 months or more,

were eligible to participate. Participants were randomised to either a nurse‐led education inter-

vention, a nurse‐led education plus ACT intervention, or a usual care. One hundred and eighteen

participants completed baseline data collection (N = 34 education group, N = 39 education plus

ACT, N = 45 control group). An intention to treat analysis was used.

Results A statistically significant reduction in HbA1c in the education intervention group was

found (P = .011 [7.48, 8.14]). At 6 months, HbA1c was reduced in both intervention groups (edu-

cation group −0.21 and education and ACT group −0.04) and increased in the control group

(+0.32). A positive change in HbA1c (HbA1c reduced) was noted in 50 participants overall. Twice

as many participants in the intervention groups demonstrated an improvement as compared to

the control group (56% of the education group, 51% education plus ACT, and 24% control group.

Conclusions At 6 months post intervention, HbA1c was reduced in both intervention groups

with a greater reduction noted in the nurse‐led education intervention.

KEYWORDS

nursing, randomised controlled trial, type 2 diabetes mellitus

1 | INTRODUCTION

Daily management of diabetes is essential in controlling blood glu-

cose, however, many people living with diabetes are unable to main-

tain glycaemic control within the recommended levels (4%‐7%,

20‐53 mmol/mol).1 Diet, exercise, stress, and medication management

are the key mediators of glycaemic control2 and areas strongly influ-

enced by self‐management through individual behaviour and action.3

The short‐term and long‐term effects of hyperglycaemia are multiple,

including microvascular changes (eg, retinopathy, nephropathy, and

Received: 1 July 2016 Revised: 18 January 2017 Accepted: 18 January 2017

DOI: 10.1111/jep.12725

J Eval Clin Pract. 2017;23:821–829. © 2017 John Wiley & Sons, Ltd.wileyonlinelibrary.com/journal/jep 821

 

 

neuropathy) and macrovascular (eg heart disease).4,5 Uncertainty does

remain around the extrapolation of population‐based risk reduction

estimations to individual predictions,6 where evidence relating to

glycaemic control and long‐term outcomes have been established

through large prospective cohorts. Further, tight glycaemic control can

result in harmful effects, for example an increase in hypoglycaemic

events.7

In addition to a global guideline on diabetes management,8 evi-

dence‐based guidelines exist across many countries on the treatment

of type 2 diabetes (eg, in another reference2) with a consistent focus

on patient education, dietary advice, managing cardiovascular risk,

managing blood glucose levels, and managing the risk of long‐term

complications. Optimal management, however, is only thought to be

reaching the minority8 with reasons such as the size and complexity

of the evidence base, the complexity of diabetes care itself, a lack of

proven cost‐effective resources for diabetes care, and diversity in

standards of clinical practice cited as driving disparities in clinical care.

The evidence on interventions to support self‐management for

people with long‐term conditions is large and attempts to draw

together individual study findings to clarify what works, for whom,

and in what contexts are available (eg, in the work of Taylor et al9).

Interventions directly related to improving the self‐management of

glycaemic control can be broadly categorised into individual and

group‐based interventions, educational and behavioural interventions,

with fewer interventions combining the latter 2 elements.10 A review

of all self‐management programmes or multicomponent interventions

aimed at self‐management; education, both group based and individ-

ual; behavioural or counselling interventions; and social support for

people living with type 2 diabetes9 reported good evidence that self‐

management support improves blood glucose control in the short‐

term, with a reduction in mean difference of around 0.4%. The

effectiveness of interventions longer term was not as strong, although

this was attributed to fewer studies reporting data at 12 months and

beyond. The impact of self‐management interventions on individuals’

quality of life and their psychological well‐being was not supported,

although equally, interventions did not have a detrimental effect. The

meta‐review was not able to pin point effective elements across inter-

ventions, instead suggesting that self‐management support may be

delivered in many ways, by different professionals and lay people,

and that in light of the large number of randomised controlled trials

and reviews included within the meta‐review the failure to reach any

conclusion on the optimal model of delivery could reflect that there

is no one way.9 The authors suggest that multiple models of delivery

may be equally effective, and consideration may instead need to be

given to other factors that may influence effectiveness, such as the

real‐world context.

Reviews with a less diverse focus have made recommendations

relating to effective elements of interventions. In relation to interven-

tions for women of African/Caribbean and Hispanic/Latin ethnicity

living in industrialised countries, 5 intervention features (hospital‐

based intervention setting; group intervention format; situational

problem‐solving; high intensity, 10 or more sessions; and incorporating

dieticians as interventionalists) were found to have a broad impact on

the majority of outcomes assessed (diet, anthropometrics, physical

activity, and hemoglobin A1c [HbA1c]). A review of behavioural

interventions (Health Quality11), found that the interventions with

the largest effects were those with higher baseline HbA1c (≥9%) and

in which the interventions were of at least 1 year in duration. A review

and meta‐analysis10 on motivational interventions in the management

of HbA1c noted that the small number of studies and issues of hetero-

geneity indicated the need for caution in interpreting the findings, and

the contribution of motivational interventions may be better assessed

by outcomes such as behaviour change.

The current study aimed to contribute to the evidence on the

effectiveness of motivational interventions and the interrelation

between self‐management behaviours and glycaemic control. Accep-

tance and commitment therapy (ACT) is a form of cognitive

behavioural therapy. The premise of ACT is the existence of a constant

interplay between the internal and external environment affecting the

individual’s overall functioning.12 Overt behaviour (actions), cognitions

(thoughts, beliefs, and perceptions), feelings, and physiology are closely

and interactively integrated, and could therefore impact the way in

which a patient manages his or her diabetes overall. Acceptance and

commitment therapy can take a holistic approach to diabetes manage-

ment including addressing psychological and motivational barriers,

acceptance of elements of management, and focuses patients on

moving in the direction of their values.13

A previous study comparing an ACT and education intervention

with an education only intervention13 found a significant improvement

in HbA1c and in acceptance of diabetes (attitudes and values) and self‐

management skills for those completing the ACT plus education inter-

vention. Building on this work, it was hypothesised that for people with

long‐term hyperglycaemia, ACT could raise participants’ awareness of

the interaction between cognitions, feelings, and behaviour and so

enable people to better self‐manage, leading to improved glycaemic

control. The objective of this study was to determine whether a

nurse‐led educational intervention alone or a nurse‐led intervention

using education and ACT were effective in reducing HbA1c in people

living with uncontrolled type 2 diabetes compared to usual care.

2 | METHODS

2.1 | Study design

The design was a 3 arm parallel group randomised controlled trial com-

paring 2 active treatment groups with a control condition. This design

was chosen over a factorial design (education alone versus ACT alone

versus education and ACT versus neither) on the premise that a certain

level of diabetes knowledge would be essential for individuals to use

the strategies developed through the ACT intervention. The half day

education intervention aimed to provide all participants in the group

with the same level of knowledge to apply the ACT strategies.

Three pairwise comparisons were planned for the analysis of out-

comes (education versus control, education plus ACT versus control,

and education versus education plus ACT). A total of 32 participants

were required in each group to achieve 80% power to detect as statis-

tically significant (2‐tailed α = 0.05) an absolute difference between

groups at 6 months in HbA1c levels of 0.5%, assuming an SD of

0.7%. The choice of effect size for power analyses was based on data

822 WHITEHEAD ET AL.

 

 

from the United Kingdom Prospective Diabetes Study14 with a 0.5%

difference in HbA1c levels regarded as being clinically significant. The

same effect size was chosen for both interventions based on the

assumption that a reduction in HbA1c of the same magnitude would

be as clinically significant for both groups. The study was granted eth-

ical approval from the Upper South B Regional Ethics Committee, New

Zealand, reference number URB/09/08/039.

2.2 | Recruitment

The inclusion criteria were a clinical diagnosis of type 2 diabetes for

12 months or more, age 18 years and over, and persistent, suboptimal

glycaemic control. This was defined as HbA1c >7%, 53 mmol/mol in the

past 12‐18 months, with at least 2 records of HbA1c >7%,

53 mmol/mol, during this period and HbA1c >7%, 53 mmol/mol on

recruitment. Exclusion criteria were non‐English speaking, pregnancy,

short‐term or serious medical conditions, and currently in psychother-

apy or participation in a diabetes education programme in the past

12 months. Following ethical approval, a range of recruitment avenues

were used including radio advertisements, adverts in community news-

letters, and newspapers and letters sent to patients who met the study

criteria through medical centres, across 1 city in New Zealand. Those

people who contacted the research assistant as interested in participa-

tion were sent a study information sheet, a consent to be contacted

form, and a stamp addressed envelope. All those who returned a con-

sent to be contacted form were called by the research assistant to

confirm inclusion eligibility, and written consent was gained to partici-

pate in the study and for the research assistant to contact the medical

centre at which they were registered to obtain HbA1c results.

Permuted block randomisation using a computer‐generated

randomisation sequence with a block size of 24 allowed for timely

randomisation of participants, where recruitment took place across a

12‐month period. A biostatistician completed the randomised alloca-

tion. The biostatistician was independent from all other study proce-

dures. The biostatistician sent information on the allocation to the

research assistant. Data were collected at baseline, 3 months following

baseline and 6 months following baseline. All study questionnaires

were sent by post together with a prepaid envelope for return.

2.3 | Description of the interventions

The decision to run the intervention on 1 day was pragmatic. The

intention was to make the intervention as cost effective and conve-

nient as possible for participants and looking to the future, for

providers who may wish to take up the intervention in practice.

Both workshops consisted of a 1 day workshop held at a central

city location. The workshop ran from 10AM to 5.30PM with a 1 hour

lunch break. The interventions were developed by the research team,

primary care nurses, and an advisory group. The main content was

based on the topic areas deemed to be important cross 3 diabetes edu-

cation programmes.12,13,15 The research team included experienced

educators and clinicians who developed a format for delivery that were

felt to promote engagement in learning and discussion and included

visual learning and active exercises, such food labelling. The interven-

tions were developed into work books for the participants and a

PowerPoint slide presentation for the presenters. The package was

reviewed by the advisory group, who included a consumer, clinicians,

and Maori and Pacific Island advisors. Both interventions were piloted

with a small group of volunteers who were diagnosed with type 2 dia-

betes but who had experienced hyperglycaemia for just less than 1 year

and so did not fully meet the study criteria. Feedback on the content

and delivery from the participants and the nurses were incorporated.

Changes were minimal and related to using 1 diagram over another,

for example, rather than changes to the topics covered.

2.4 | The education intervention

The education intervention sessions were run by 2 primary health care

based nurses who were trained in the delivery of the intervention by 2

of the study investigators. The education intervention covered the

topics of the basic pathophysiology of diabetes, understanding diabe-

tes and glucose, understanding the risk factors and complications asso-

ciated with diabetes, food groups, portion sizes, self‐management of

diabetes through diet, exercise, medication, and stress management,

monitoring diabetes, including awareness of hypo and hyperglycaemia,

and when to seek help. Underpinning the content were the themes of

increasing understanding, how to take control and planning for the

future. The intended changes related to increasing understanding of

diabetes, satisfaction with diabetes management, an increase in self‐

management activities, and maintenance or improvement of mental

health, as measured through anxiety and depression.

2.5 | The education plus ACT intervention

In the education plus ACT intervention, time was divided equally

between the education intervention and the ACT intervention to main-

tain the same amount of contact time between participants and the

nurses. Participants received the same content in education but did

not have the opportunity to discuss the material in as much depth as

the education only group nor spend as much time on self‐directed

exercises in the handbook during the workshop. The ACT component

addressed mindfulness and acceptance training in relation to difficult

thoughts and feelings about diabetes, exploration of personal values

related to diabetes, and a focus on the ability to act in a valued direc-

tion while contacting difficult experiences. The ACT component drew

on material developed in a previous study.13 The workshop was led

by a mental health nurse with expertise in ACT who received supervi-

sion from a clinical psychologist. The education component was

delivered by one of the nurses providing the education intervention.

The intended changes related to increased acceptance of diabetes‐

related thoughts and feelings and a reduction in the extent to which

thoughts and feelings interfere with valued action, increase in under-

standing of diabetes, satisfaction with diabetes management, an

increase in self‐management activities, and maintenance or improve-

ment of mental health, as measured through anxiety and depression.

2.6 | Fidelity

The fidelity of the intervention was enhanced through the develop-

ment of a manual for both interventions; all sessions were recorded

and reviewed by LW and JC for adherence to the protocol and

WHITEHEAD ET AL. 823

 

 

manuals, and 1 nurse participated in all of the intervention sessions to

enhance continuity of style and content of the sessions.

2.7 | Control group

The control groups were mailed the questionnaires at the same time

points as the 2 intervention groups. Participants in the control group

continued to receive routine diabetes care. Routine care generally

comprised visits to the GP/practice nurse as initiated by the patient

with an annual invitation by the practice to attend for a health check

involving measurement of HbA1c (goal ≤7%), weight, blood pressure

(goal 13/80), total cholesterol (goal ≤4), HDL cholesterol (goal ≥1),

LDL cholesterol (goal <2), triglycerides (goal <1.7), microalbuminuria

(ratio < 3), date of last eye examination (at least every 2 years), foot

check, and sensation and pulses. The control groups were not offered

the opportunity to participate in an intervention posttrial.

2.8 | Outcome measures

The primary outcome variable was glycaemic control (HbA1c). The sec-

ondary outcome variables were acceptance of diabetes‐related

thoughts and feelings and extent to which thoughts and feelings inter-

fere with valued action, increase in understanding of diabetes, satisfac-

tion with diabetes management, an increase in self‐management

activities, and maintenance or improvement of mental health, as

measured through anxiety and depression.

2.9 | Glycaemic control

HbA1c was analysed by a local medical laboratory. Participants were

asked to either visit their local medical laboratory, widely distributed

throughout the city, or if required a mobile phlebotomist who took

the sample at the participant’s home. The phlebotomist was blinded

to the group allocation of participants. Time points for measurement

were at baseline, 3 months and 6 months. A 2‐week window was

allowed around the designated data collection time points.

The questionnaires were self‐administered. They were sent to the

participant’s postal address and returned in a stamp addressed enve-

lope. The pack contained information on who to contact if assistance

was required (the research assistant), however, no one made contact

for support to complete the questionnaires.

2.9.1 | Acceptance of diabetes

The Acceptance and Action Diabetes Questionnaire (AADQ)13 is an 11

item Likert type scale to measure acceptance of diabetes‐related

thoughts and feelings and the extent to which they interfere with

valued action (eg, I avoid thinking about what diabetes can do to

me). The scale has demonstrated good inter‐rater reliability (Cronbach

α = .94). Scores range from 11 to 55 with a higher score reflecting

greater nonacceptance.

2.9.2 | Anxiety and depression

Anxiety and depression were measured through the Hospital Anxiety

and Depression Scale (HADS).16 The HADS has been used extensively

in research and has been shown to have good validity, specificity and

sensitivity,17 and good test‐retest reliability.18 Although the HADS is

a screening tool, it correlates well with clinical assessments of anxiety

and depression. A score is generated for anxiety and depression, both

ranging from 0 to 21 with a score of 0‐7 indicating subclinical symp-

toms, 8‐10 possible clinical levels and a score of 11 or over probable

clinical levels.

2.9.3 | Understanding of the management of diabetes

Understanding of the management of diabetes was assessed by a sub-

scale of the Diabetes Care Profile (Cronbach α = .60‐.95).19 The Diabe-

tes Care Profile comprises 14 subscales in total. The understanding

subscale comprises 10 items and explores understanding of key

aspects of the management of diabetes, eg, “How do you rate your

understanding of diet and blood sugar control?” Reliability was

explored in 2 large studies, a community study (n = 440) and medical

centre study (n = 352). Reliabilities (Cronbach alpha) of the under-

standing subscale were reported as .92 and .92 respectively.19 Scores

range from 10 to 50, with a higher score indicating better self‐rated

understanding of diabetes.

2.9.4 | Diabetes treatment satisfaction

The DiabetesTreatment Satisfaction Questionnaire (DTSQ)20 was used

to measure satisfaction with diabetes treatment. The 6 item scale

assesses treatment satisfaction and 2 items assess perceived frequency

of hyperglycaemia and hypoglycaemia. Ceiling effects have been noted

with the DTSQ and the DTSQ change (DTSQc) was developed to over-

come these.21 The authors recommend using the DTSQ first to anchor

the findings, followed the DTSQc to explore how people’s satisfactions

with perceived hypoglyacaemia and hyperglycaemia have changed. The

DTSQ has been widely used and is recommended by the World Health

Organisation and the International Diabetes Federation as useful in

assessing outcomes of diabetes care.22 On the DTSQ, each of the 8

items are scored on a scale of 0‐6 with a higher score indicating greater

satisfaction. For the DTSQc, each item is scored on a scale of −3 to +3

with a higher score indicating greater satisfaction.

2.9.5 | Diabetes self‐care activities

The summary of diabetes self‐care activities measure was used to

assess self‐care activity.23 Three of the 8 subscales; general diet, exer-

cise, and blood glucose testing were used in this study. The inter‐rater

reliability, measured by means of the Cronbach alpha coefficient,

ranged from 0.66 to 0.80 for the 3 subscales independently24,25 and

a Cronbach alpha of 0.71 for the 3 subscales collectively as measured

using all baseline data from this study.

The subscale general diet includes 2 questions: How many of the

last 7 days have you followed a healthy eating plan? And over the past

month, how many days/week have you followed your eating plan? The

exercise component questions on how many of the last 7 days did you

participate in at least 30 minutes of physical activity? On how many of

the last 7 days did you participate in a specific exercise session other

than what you do around the house/work? And the blood glucose sub-

scale, on how many of the last 7 days did you test your blood sugar?

and On how many of the last 7 days did you test your blood sugar

the recommended number of times? The derived scores reflect the

number of days within a week recommended activity related to diet,

824 WHITEHEAD ET AL.

 

 

exercise, and blood glucose monitoring have been followed. The range

is 0‐42, with a higher score reflecting greater self‐management.

2.9.6 | Data analysis

Statistical analyses were performed using the Statistical Package for

the Social Sciences, version 19 (Statistical Package for the Social Sci-

ences In, Chicago, Illinois). Standard descriptive statistics were used

to summarise demographic and clinical characteristics for the

randomised groups. Analyses were conducted on an intention‐to‐treat

basis, which included all participants who completed the baseline ques-

tionnaires, a blood test for HbA1c and in the intervention groups, who

attended the workshop. Missing values were handled according to the

guidelines for each scale. An analysis of covariance (ANCOVA) was

used to compare the HbA1c levels at 6 months between randomised

groups where the randomised group was treated as a fixed factor

and the baseline value for HbA1c (taken within 3 months of commenc-

ing the study) as a covariate. If a significant effect (P < .05) of

randomised group was identified from the ANCOVA, then pairwise

comparisons of each intervention group with the usual care were

undertaken. The ANCOVA was also used to compare the secondary

outcomes using randomised group as a fixed factor and the relevant

baseline level as a covariate.

2.10 | Results

2.10.1 | Recruitment outcomes and sample description

Over a 12‐month period, 303 people responded and following assess-

ment for eligibility; 172 people who met the study criteria were

approached. One hundred and fifty seven participants with glycaemic

control outside of the recommended range for over 12 months gave

informed consent and were randomised to one of 3 groups, education,

education plus ACT, or usual care (control). In total, 51 participants

were randomised to the education only intervention, 54 to the educa-

tion plus ACT intervention, and 52 to the control group. A total of 34

participants declined to participate postrandomisation; 14 participants

had moved away or were no longer contactable, and 25 participants

had changed their minds, mostly related to lack of time.

The differences in baseline characteristics across the 3 randomised

groups were not significantly different (Table 1).

At 6 months, 21 people did not complete a blood test for HbA1c

level and 12 participants did not complete and return the question-

naires. Baseline analysis found no difference between those lost to fol-

low up and those who completed the study. Intention to treat analysis

was conducted. Figure 1 outlines the trial profile.

2.10.2 | Effects on glycaemic control

At 6months, HbA1cwas reduced in both intervention groups (Education

group −.21, education plus ACT group −.04) and increased in the control

group (+.32). The primary outcome results are presented inTables 2, 3.

An ANCOVA using HbA1c prescores as the covariate found signif-

icant differences between the participants’ HbA1c at 6 months

(F (2,114) = 3.29, P = .04). Planned contrasts found no statistical differ-

ence in HbA1c at 6 months between the control group and the educa-

tion plus ACT group (P = .079 [7.61, 8.23]). The mean difference in

HbA1c between the control group and education intervention group

at 6 months was statistically significant (P = .011 [7.48, 8.14]).

Exploring change in HbA1c by direction (positive, none, or negative)

showed that, proportionally, twice as many participants in the inter-

vention groups demonstrated a reduction in HbA1c compared to the

control group (Table 3).

A positive change in HbA1c (HbA1c reduced) was noted in 50 par-

ticipants overall (56% education group, 51% education and ACT, and

24% control group).

2.10.3 | Effects on secondary and safety outcomes

The analyses of the secondary measures are presented in Table 4. No

significant differences between the conditions in participants’ accep-

tance of diabetes (AADQ), anxiety and depression, understanding of

diabetes, satisfaction with treatment, or satisfaction with blood glu-

cose control. Close to significant between group differences were

noted in self‐management practices. Self‐management activities

improved in the education plus ACT group but decreased in the educa-

tion group to a result reflective of the control group.

Potential adverse events such as episodes of hypoglycaemia were

not systematically recorded. Based on episodically reported informa-

tion, no serious events of hypoglycaemia were recorded in either study

group.

TABLE 1 Demographic details

Age, mean in years (SD)

Education (N = 34) Education & ACT (N = 39) Usual Care (N = 45) 53.76 (8.68) 56.1 (6.91) 56.4 (6.97)

Gender N % N % N %

Male 20 59 17 44 26 58

Female 14 41 22 56 19 42

Ethnicity

NZ European 24 71 35 90 36 80

Maori 3 9 0 0 5 11

Time since diagnosis

<5 years 13 38 10 26 14 31

5‐9 years 9 26 14 36 14 31

>10 years 12 36 15 38 17 38

Abbreviation: ACT, acceptance and commitment therapy.

WHITEHEAD ET AL. 825

 

 

3 | DISCUSSION

In this study, the HbA1c level was reduced in both intervention groups

and this change was statistically significant in the education only group

at 6 months postintervention. No effects on secondary outcomes were

found. The results of this study indicate that a 1 day nurse‐led group

intervention can have an impact on diabetes management up to

6 months postintervention. An earlier study13 found a significant

decrease in HbA1c in an education plus ACT group and a significant

change (improvement) in acceptance of diabetes as measured by the

AADQ and in self‐management. In this study, no significant changes

on any variable were noted for the education plus ACT group as com-

pared to the control group or education only group. Although the cur-

rent study did not seek to replicate the Gregg et al study, we did use

similar principles and material in developing the intervention. A

difference in the characteristics of participants by mean years since

diagnosis was noted between the studies, 5.3 years13 vs 10.03 years

in the current study. It could be hypothesised that the difference in

outcome between the studies was related to time since diagnosis

and that this influenced the ability to change attitudes and values

towards diabetes. The potential impact of time since diagnosis on

study design and outcome requires further consideration.

In the interventions in this study, and especially so in the educa-

tion plus ACT group, participants were asked to deal with attitudes

towards diabetes and self‐care, to observe negative feelings and to

reflect on values in life. While this could be challenging and result in

increased worry and anxiety about life and diabetes, participants

showed stable or improved scores on all psychological variables.

FIGURE 1 Trial profile. ACT, acceptance and commitment therapy; HbA1c, hemoglobin A1c

TABLE 2 HbA1c levels at baseline, 3 months and 6 months

Baseline 3 months 6 months Difference

Usual care 8.08 8.13 8.40 +0.32

Education 8.13 7.80 7.92 ‐0.21

Education + ACT 7.78 7.73 7.74 ‐0.04

Abbreviations: ACT, acceptance and commitment therapy; HbA1c, hemoglobin A1c.

TABLE 3 Direction of change in HbA1c

Direction of change

Positive N (%) None N (%) Negative N (%) Total

Control 11 (24) 4 (9) 30 (67) 45

Education 19 (56) 2 (6) 13 (38) 34

Education + ACT 20 (51) 1 (3) 18 (46) 39

50 7 61 118

Abbreviations: ACT, acceptance and commitment therapy; HbA1c, hemo- globin A1c.

826 WHITEHEAD ET AL.

 

 

Any intervention seeking to reduce HbA1c levels raises concern

around increase of hypoglycaemic episodes. In this study, there was

no evidence that participants experienced episodes of hypoglyacaemia

and no reports of a medical emergency related to hypoglycaemia,

although we did not specifically collect data on blood glucose levels

outside of the primary measure of HbA1c nor did we directly seek feed-

back on experiences of hypoglycaemia nor of fear of hypoglycaemia.

Both individual and group settings have been used for cognitive‐

behavioural interventions, with no definitive conclusion as to which

setting is more effective.26,27 The literature on educational interven-

tions for diabetes self‐management favours the group setting,28

although the specific aspects of group intervention that are effective

have not been isolated. It is unclear how the group process contributed

to outcomes, and this requires further investigation.

The delivery of interventions in a group setting has obvious cost

advantages in the clinical setting. This study has also shown that a

nurse‐led intervention is effective in reducing HbA1c. The nurses in

this study did not receive costly training and although specialists pro-

vided oversight, they did not contribute to the intervention. These

findings are of significance in the clinical setting where the ability to

draw on staff involved in the regular care of the patient in the primary

care setting is both cost‐effective and more realistic in embedding

interventions into clinical practice. What is not known is whether the

input of specialists or of peer leadership would have been more effec-

tive and remains an area for future exploration.

It is unclear how long the positive effects of the interventions on

glycaemic control observed in this study will last. Taylor et al9 noted

diminished effects at 12 months and beyond amongst intervention

studies to improve self‐management of type 2 diabetes. Based on ear-

lier literature, it is likely that maintenance sessions would be required to

sustain the effect shown.29 Connecting with community partners and

other chronic care model programmes running in the community has

proven to be a successful adjunct to cognitive‐behavioural interven-

tions, allowing the effects to be sustained as far out as 3 years postin-

tervention.24,30,31 Incorporating booster sessions enhances the

effectiveness of self‐management interventions, however, health care

providers are challenged in providing continued self‐management sup-

port over time and as needed by individuals. Reaching patients between

visits and tailoring information and support to meet specific needs

could be addressed more successfully through the use of technology

TABLE 4 Effects on secondary outcome measures

Pretreatment Posttreatment (6 months follow‐up)

M SD 95 % CI M SD Intragroup difference 95 % CI F‐test (ANCOVA

between groups effects)

Acceptance of diabetes

Usual care 67.8 32.02 56.17‐79.70 70.53 33.36 −1.34 63.10‐77.26 P < .21

Education 71.76 28.77 56.64‐81.26 76.42 32.97 −4.66 69.19‐84.75

Education + ACT 68.03 28.17 58.08‐85.61 69.03 27.54 −1 59.36‐75.56

Anxiety

Usual care 5.6 4.57 4.35‐7.31 5.59 4.9 0.01 4.04‐7.13 P < .98

Education 4.62 4.13 2.98‐6.48 4.81 3.82 −0.19 3.27‐6.35

Education + ACT 5.5 3.64 4.30‐6.70 5.54 3.66 −0.04 4.24‐6.65

Depression

Usual care 4.1 3.6 3.23‐5.55 3.49 3.01 0.61 2.64‐3.72 p < .95

Education 3.53 2.82 2.25‐4.52 2.73 2.68 0.8 2.69‐3.93

Education + ACT 3.87 3.45 2.73‐5.0 3.33 3.21 0.54 2.66‐3.83

Understanding

Usual care 3.4 1.31 2.92‐4.10 3.7 1.72 −.03 3.15‐3.94 P < .53

Education 3.09 0.72 2.75‐3.40 4.06 1.68 −0.97 3.50‐4.40

Education + ACT 3.13 0.78 2.85‐3.50 4.03 1.23 −0.9 3.68‐4.53

DTSQ‐satisfaction

Usual care 13.13 2.95 24.37‐28.69 6.83 6.71 −6.21 6.47‐11.24 P < .60

Education 12.13 4.5 20.03‐28.47 8.12 8.78 −4.62 7.15‐12.72

Education + ACT 13.67 3.16 24.80‐29.90 8.85 5.13 −5.57 6.26‐11.47

DTSQ‐blood glucose control

Usual care .94 1.21 3.12‐4.88 .41 2.06 1.45 −.039‐1.22 P < .48

Education 1.93 1.08 2.84‐4.86 −0.18 2.24 1.97 −1.24‐0.86

Education + ACT 1.88 1.0 2.96‐4.58 0.62 2.23 1.27 −0.23‐1.47

Self‐management

Usual care 9.77 4.62 8.33‐12.31 9.73 4.78 0.04 8.74‐11.36 P < .07

Education 10.30 4.25 9.04‐12.58 9.5 5.16 0.83 7.83‐11.09

Education + ACT 10.81 4.78 12.05‐13.28 12.17 4.05 −1.36 10.39‐13.25

Abbreviations: ACT, acceptance and commitment therapy; ANCOVA, analysis of covariance; CI, confidence interval; DTSQ, DiabetesTreatment Satisfaction Questionnaire.

WHITEHEAD ET AL. 827

 

 

(eg, the Internet, web‐based education, text messaging, email, auto-

matic telephone reminders, and telehealth/telephone education

and reinforcement). Although the evidence on the effectiveness of

e‐health is mixed, it is gathering momentum and has been proven

effective in the management of HbA1c (eg, in other studies 25,32)

and offers a time‐efficient means of providing ongoing support.

In summary, the nurse‐led education intervention is a promising

approach in improving outcomes for those with type 2 diabetes and

long‐term, less than optimal glycaemic control. Further research to

explore the value of group sessions over individual interventions, the

relative benefits of ACT versus education, the impact of maintenance

sessions, and follow‐up over a longer time period would enhance

understanding of the value and role of interventions to support

glycaemic control.

ACKNOWLEDGEMENTS

L.W. wrote the manuscript and researched data. M.C., J.C., V.M., D.C.,

C.B., and C.F. contributed to the design and conduct of the study,

analysis of data, and write‐up. The study was funded by the Strategy

to Advance Research in Nursing and Allied Health (STAR). The funder

did not play any role in the conduct of the study.

CONFLICT OF INTEREST

The authors declare no conflict of interest.

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How to cite this article: Whitehead LC, Crowe MT, Carter JD

et al. A nurse‐led education and cognitive behaviour therapy‐

based intervention among adults with uncontrolled type 2 dia-

betes: A randomised controlled trial. J Eval Clin Pract.

2017;23:821–829. https://doi.org/10.1111/jep.12725

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