Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000095561
Ethics application status
Approved
Date submitted
3/05/2014
Date registered
4/02/2015
Date last updated
4/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalising eye consultations to improve outcomes in diabetic retinopathy
Scientific title
A randomised controlled trial of a personalised eye consultation on glycaemic control in people with type 2 diabetes and diabetic retinopathy
Secondary ID [1] 284533 0
None
Universal Trial Number (UTN)
Trial acronym
PEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic retinopathy 291794 0
Poor glycaemic control 291795 0
Condition category
Condition code
Eye 292156 292156 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 294350 294350 0 0
Diabetes
Public Health 294351 294351 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to one of 3 groups. One group will receive a personalised eye consultation followed by 5 follow up support telephone consultations, a second group will receive a personalised eye consulatation (without the follow up support over the phone) and a third (control) group will receive continued access to usual care from their ophthalmologist.

In an in-person consultation, the participant’s own retinal image will be used to explain the status of their diabetic retinopathy and its likely progression in reference to other images of diabetic retinopathy stages. The link between diabetic retinopathy progression, blood glucose control and health behaviours will be explained. The interventionist (an orthoptist, whose major role is to support the ophthalmologist in clinical settings), will then facilitate the participant to set individually tailored goals specifically related to improving blood glucose control (e.g. changes to diet, physical activity). This personalised eye consultation (PEC) is based on HealthChange (trademark) Methodology, developed by Janette Gale with whom we have worked closely in developing our model. This model is a client-centred clinical practice framework grounded in evidence-based psychological theories and principles including Social Cognition Theory, Motivational Interviewing, Solution-focused Counselling, Theory of Planned Behaviour, and the Transtheoretical Model. Our PEC manual outlines a 10-step approach including sample scripts which are tailored to the patients’ existing level of knowledge, motivation and confidence. Based on our pilot work and experience of using the HealthChange (trademark) Methodology, we estimate that the consultation should take 60 - 90 mins.

Participants randomised to receive telephone support will receive 5 telephone behaviour change support sessions (in addition ot the personalised eye consultation). These will be delivered at approximately 2, 4, 8, 14 and 20 weeks following the personalised consultation. All behaviour change support sessions will be guided by scripts and are designed to be approximately 15 - 30 minutes in duration. The aim of these sessions is to support the behaviour change processes by prompting additional goal setting, discussing ways to overcome obstacles to health behaviour change and strengthening skills in decision-making, problem-solving and goal planning
Intervention code [1] 289295 0
Behaviour
Comparator / control treatment
Participants will receive usual care (eye checks once a year and the use of insulin/medication/diet to manage diabetes) from their ophthalmologist and GP. Participants will also be advised to seek support from their diabetes care team to improve their diabetes management.
Control group
Active

Outcomes
Primary outcome [1] 292035 0
Glycosylated haemoglobin (HbA1c) result obtained from a blood test
Timepoint [1] 292035 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Primary outcome [2] 292036 0
Fasting blood glucose obtained from a blood test
Timepoint [2] 292036 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [1] 308040 0
The 16 item Diabetes Self-Management Questionnaire (DSMQ) will provide an overview of diabetes self-management activities (Schmitt et al., 2013)
Timepoint [1] 308040 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [2] 308041 0
Self-efficacy will be assessed using the 8-item Perceived Diabetes Self-Management Scale (PDSMS- Wallston et al., 2007)
Timepoint [2] 308041 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [3] 308042 0
Diabetes distress will be measured using the 2-item screening tool, the Diabetes Distress Scale (Fisher et al., 2008).
Timepoint [3] 308042 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [4] 308043 0
Knowledge of diabetic retinopathy will be assessed with the Diabetic Retinopathy Health Literacy (DRHL) Scale, developed by investigators Rees and Lamoureux. The DRHL is currently undergoing validation using both classical test theory and item response theory.
Timepoint [4] 308043 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [5] 308044 0
Motivation and behavioural intentions will be assessed using the contemplation ladder adapted to diabetes management study specific questions regarding intentions (Rees et al., 2013).
Timepoint [5] 308044 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [6] 308045 0
Beliefs about diabetic retinopathy will be assessed using the 9 item Brief Illness Perceptions Questionnaire (BIPQ, Broadbent et al., 2006).
Timepoint [6] 308045 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [7] 308050 0
Alcohol consumption will be assessed using alcohol rating scale from the Food Frequency Questionnaire (FFQ, Smith et al., 1998).
Timepoint [7] 308050 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [8] 308051 0
Frequency of self-monitoring of blood glucose will be assessed using the Summary of Diabetes Self-Care Activities measure(SDSCA, Toobert, 2000)
Timepoint [8] 308051 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [9] 308052 0
Well being will be assessed using the 5 item WHO-5 Wellbeing Index (Bech et al, 2003)
Timepoint [9] 308052 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [10] 308053 0
Stress will be measured using the 10 item Perceived Stress Scale (Cohen et al., 1983)
Timepoint [10] 308053 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [11] 308054 0
Blood pressure will be assessed using an automated machine.
Timepoint [11] 308054 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [12] 308055 0
High density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides values will be obtained from blood samples.
Timepoint [12] 308055 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [13] 308056 0
Height and weight (to calculate body mass index) will be assessed using a wall-mounted adjustable measuring scale and a calibrated scientific weight scale.
Timepoint [13] 308056 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [14] 308057 0
Self regulation will be assessed with the Short Self-Regulation Questionnaire (SSRQ, Neal, 2005)
Timepoint [14] 308057 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up.
Secondary outcome [15] 312622 0
Quality of life will be assessed using the EQ-5D-5L (EuroQoL, 1990)
Timepoint [15] 312622 0
Outcome will be assessed at baseline and 3 months, 6 months and 12 months follow-up

Eligibility
Key inclusion criteria
Inclusion criteria will be: (a) diagnosis of type 2 diabetes. We have chosen to focus only on type 2 diabetes given the epidemic of type 2 diabetes, and also as most of our public DR patients have this form. Additionally, we wish to keep our sample as homogenous as possible given the natural history and management of type 2 is very different from type 1 diabetes; (b) a score of 20-51 on the Early Treatment Diabetic Retinopathy Study (ETDRS) grading scale suggesting mild to moderate non proliferative diabetic retinopathy; (c) suboptimal HbA1c (greater than or equal to 8%)) at baseline assessment. We chose a conservative 8% cut-off point for our study to reach those in greatest need and to avoid adverse consequences (hypoglycaemia) of tight control; (d) no previous treatment for diabetic retinopathy (e.g., laser or anti-vascular endothelial growth factor) or indication of imminent treatment; (e) at least 18 years old; (f) no cognitive deficit, as assessed by the 6-item cognitive impairment test; (g) ability to communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be invited to attend an appointment at which all eligibility criteria, including HbA1c will be assessed, and a retinal image will be taken for each eye. Those meeting the eligibility criteria will be invited to take part in the trial and, if they consent, a baseline appointment will be scheduled. All assessment appointments will take place at the Centre for Eye Research Australia (CERA). Following baseline assessment, participants will be allocated randomly to one of the three arms based on a computer generated random number sequence, organised by a CERA clinical trials expert (with no participant contact).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated randomly to one of the three arms based on a computer generated random number sequence, organised by a CERA clinical trials expert (with no participant contact).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline data: Descriptive statistics and bivariate comparisons of participants by treatment group will be conducted to characterise the sample and assess the success of randomisation. Continuous variables will be summarised as either mean (SD) or median (interquartile range). Independent-samples t-tests or analysis of variance (ANOVA) will be used to detect statistical significance for normally distributed data, and non-parametric tests will be used for skewed data. Categorical variables will be summarised by frequencies and proportions, and Pearson Chi-square tests or Fisher’s exact tests will be selected to compare the difference between three groups. Any imbalances of characteristics between the groups will be adjusted for in subsequent analysis. Missing data: The differences between the three groups in the proportion and reason of patients’ withdrawals will be compared using the Chi-squared test. The multiple imputations method will be used to handle missing data if necessary. Analysis population: The patient population under study will be defined as intention-to-treat (ITT), which includes all participants who were randomised. Validation of measurement tools: We will use Item Response Theory (IRT) to maximize the validity and accuracy of our measurement tools. Rasch analysis, a special case of IRT, is based on a probabilistic measurement model that identifies a unidimensional construct, measures its validity, and provides estimates of item and person measures on an interval scale. Rasch analysis improves scoring accuracy and precision.

We will conduct descriptive exploratory analyses of changes in the primary outcome (HbA1c) over time before fitting statistical models to identify important features of changes. We expect the change in HbA1c to be normally distributed and analysis of covariance (ANCOVA) will be used to compare differences between the three groups, adjusting for baseline values. Effect sizes will be calculated using Cohen's d coefficient. To examine secondary outcomes, a multivariable General Linear Model method will be used with 3-, 6- and 12-month differences from baseline. Path analysis will be used to examine mediators of intervention outcomes. Briefly, these include statistical tests of: (a) the intervention’s effect on the primary outcome; (b) the intervention’s effect on the potential mediator; (c) the effect of the potential mediator on the outcome variable, after controlling for the effect of the intervention; and (d) the mediated effect, or the indirect path from the intervention to the potential mediator to the outcome.

Our sample size is 186. This was calculated based on numbers required to detect a minimum of 0.6% change in HBA1c. This is a clinically meaningful reduction in HbA1c given that previous research has indicated that a 1% reduction corresponds to a 25% reduction in microvascular complications (Fenwick et al 2013). The total sample required to detect this change with 80% power (p greater than 0.05) is 120. Taking into account an estimated non-response (10%) and loss to follow-up (20%), the total sample size required is 171 (i.e. 57 in each of the three trial arms). We also computed sample size requirements for our secondary outcomes. For example, based on our pilot study values on the Summary of Diabetes Self-Care Activities specific diet subscale (mean equals 4.66 plus or minus 1.6), an improvement of 15% requires a sample size of 129 (80% power, p greater than 0.05). Taking into account 30% attrition, this is a total sample size of 184. Therefore to assess all outcomes with sufficient power, a total sample of 186 is required (i.e. 62 in each of the three trial arms).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/02/2015
Actual
Date of last participant enrolment
Anticipated
21/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2395 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [2] 2396 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 2397 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9156 0
3002 - East Melbourne
Recruitment postcode(s) [2] 9157 0
3181 - Prahran
Recruitment postcode(s) [3] 9181 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 289165 0
Charities/Societies/Foundations
Name [1] 289165 0
This project is funded by a Millennium Grant from Diabetes Australia Research Trust
Country [1] 289165 0
Australia
Funding source category [2] 290648 0
University
Name [2] 290648 0
Centre for Eye Research Australia (University of Melbourne)
Country [2] 290648 0
Australia
Primary sponsor type
University
Name
Centre for Eye Research Australia (University of Melbourne)
Address
32 Gisborne Sreet , East Melbourne, VIC, 3002
Country
Australia
Secondary sponsor category [1] 287834 0
None
Name [1] 287834 0
Address [1] 287834 0
Country [1] 287834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290937 0
Human Research and Ethics Committee, Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 290937 0
Ethics committee country [1] 290937 0
Australia
Date submitted for ethics approval [1] 290937 0
Approval date [1] 290937 0
20/01/2014
Ethics approval number [1] 290937 0
13/1150H
Ethics committee name [2] 290938 0
Human Research and Ethics Committee, St Vincent's Hospital (Melbourne)
Ethics committee address [2] 290938 0
Ethics committee country [2] 290938 0
Date submitted for ethics approval [2] 290938 0
Approval date [2] 290938 0
13/01/2014
Ethics approval number [2] 290938 0
HREC-A 137/13
Ethics committee name [3] 290939 0
Human Research and Ethics Committee, The Alfred Hospital
Ethics committee address [3] 290939 0
Ethics committee country [3] 290939 0
Australia
Date submitted for ethics approval [3] 290939 0
Approval date [3] 290939 0
20/01/2014
Ethics approval number [3] 290939 0
562/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 44 44 0 0
/AnzctrAttachments/366255-RVEEH HREC Approval letter.pdf
Attachments [2] 45 45 0 0
/AnzctrAttachments/366255-St Vincent's HREC Approval letter.pdf
Attachments [3] 46 46 0 0
/AnzctrAttachments/366255-The Alfred HREC Approval letter.pdf

Contacts
Principal investigator
Name 48078 0
Dr Gwyneth Rees
Address 48078 0
Centre for Eye Research Australia
32 Gisborne St
East Melbourne VIC 3002
Country 48078 0
Australia
Phone 48078 0
+61 3 9929 8370
Fax 48078 0
+61 3 9929 8030
Email 48078 0
[email protected]
Contact person for public queries
Name 48079 0
Prue Spencer
Address 48079 0
Centre for Eye Research Australia
32 Gisborne St
East Melbourne VIC 3002
Country 48079 0
Australia
Phone 48079 0
+61 3 9929 8174
Fax 48079 0
+61 3 9929 8030
Email 48079 0
[email protected]
Contact person for scientific queries
Name 48080 0
Gwyneth Rees
Address 48080 0
Centre for Eye Research Australia
32 Gisborne St
East Melbourne VIC 3002
Country 48080 0
Australia
Phone 48080 0
+61 3 9929 8370
Fax 48080 0
+61 3 9929 8030
Email 48080 0
[email protected]

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