Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001010482
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
1/08/2016
Date last updated
1/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot randomised control trial of a problem-solving intervention tailored to quality of life difficulties experienced by patients with diabetic retinopathy
Scientific title
Pilot randomised control trial of a problem-solving intervention tailored to quality of life difficulties experienced by patients with diabetic retinopathy
Secondary ID [1] 289719 0
None
Universal Trial Number (UTN)
Trial acronym
DMP_INT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic retinopathy 299550 0
Diabetes 299551 0
Condition category
Condition code
Metabolic and Endocrine 299627 299627 0 0
Diabetes
Eye 299628 299628 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention arm will receive six (minimum) or eight (maximum) complete weekly problem-solving training (PST) sessions provided by trained eye care staff. The first PST session will be combined with the introductory session which will be delivered as an individual one-on-one session (face to face). The remaining PST sessions will be conducted over the telephone and the participant can decide whether they feel they need the 7th and 8th session, which are optional. Between sessions, participants will be expected to attempt to put problem solving techniques into practice and develop goals necessary to fulfill solutions to problems. Progress review will be conducted at the beginning of each session. All telephone calls are recorded and the frequency and duration of each session monitored.

Introductory session
The introductory session will briefly recap an overview of diabetes with targeted awareness of diabetic retinopathy (DR) risk factors; HbA1c targets, blood pressure, cholesterol, obesity. From here, a discussion on how DR impacts upon a person’s quality of life will be presented. This will followed by explaining the nature of, and rationale behind, PST in the context of diabetes and DR related quality of life (QoL). Participants will be informed of the overall goal of PST which is to present and apply problem solving skills to assist them to live a fuller life despite their DR and the chronic nature of their diabetes. Thus the main goal is to modify the participant’s perceptions and beliefs that may interfere with attempts to engage in optimal problem solving efforts and ultimately optimal self-management practices. An explanation regarding the format and time interval of PST sessions will be discussed.
The introductory session will be the gateway to highlighting individual QoL problem areas faced by the participant. Responses from the primary diabetes related QoL questionnaire; the Diabetes Distress Scale (DDS), will be discussed. Responses from the DDS will form the basis of a ‘problem list’. The problem list will then be used to guide the order in which the participant chooses to address each problem. Discussions around diabetes distress and QoL can be enhanced by use of the “Wheel of Life” which is a method of encouraging discussion around how diabetes affects the main areas of an individual’s life. This approach may assist the PST process by identifying the issues surrounding the problem.
The number of problems discussed will be tailored to each participant. Some problems may need more than one session to solve. Each PST session is expected to last around 45 to 60 minutes and will aim to apply the full problem solving technique (discussed below) to address a single problem area per intervention session.

Problem Solving Sessions
The basis of PST is guiding the participant through a systematic 7 stage process. Briefly, the 7 stages address the following: (Manual available with complete details).
1. Selecting and defining the problem
The first step of the PST process is to describe all aspects surrounding the problem such as the ‘when, where, how’ the problem occurs.
2. Set realistic goals
The second step is to set a goal orientated around the way the participant would like to see the problem change.
3. Brainstorming
Brainstorming involves encouraging the participant to think about as many possible and differing solutions to the problem.
4. Pros and Cons
The participant is facilitated to consider the pros (advantages) and cons (disadvantages) for each possible solution that is reported. This process involves considering the impact of potential obstacles and barriers to achieving solutions, for example the influence of time, money and family support.
5. Choose the most feasible solution
The participant is facilitated to choose the most appropriate and appealing solution/s to the problem.
6. Determine a plan of action
Once a solution/s is selected, a plan entailing all the individual steps to achieving the solution is constructed with the participant. This includes the ‘who, what, when and how’ details in carrying out a series of actions leading to resolving the problem. For example, what specifically needs to done, how frequently, how often and how practices can be weaved into the participant’s routines and lifestyle.
7. Evaluate the outcome at next visit
A review of a participant’s adoption of problem solving techniques and skills is required at this step. This is combined with consideration of how PST has worked for individual problems and whether ongoing attention is required in certain areas, whether this be related to the actual problem itself or in the action plan surrounding goal setting, needs refinement.
Intervention code [1] 295355 0
Behaviour
Intervention code [2] 295484 0
Treatment: Other
Comparator / control treatment
Participants randomised to this arm will be followed at the Royal Victorian Eye and Ear Hospital pragmatically and has the same face to face follow ups as the intervention group. They have access to the internal diabetes educator as deemed appropriate by their treating Ophthalmologist (= usual care).

All participants will be questioned, using a check list, at each follow up regarding any potential factors that may influence their diabetes control in-between assessments such as changes in medication/s, number of sick days, negative life events and periods of medication non-adherence.
Control group
Active

Outcomes
Primary outcome [1] 299006 0
Diabetes Distress Scale (DDS)
This is a 17 item questionnaire that assesses diabetes related emotional distress across 4 domains; emotional burden, physician, regimen and interpersonal related. Developed from the PAID and QSD-R
Timepoint [1] 299006 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [1] 325852 0
Patient Health Questionnaire (PHQ-9)
This 9 item questionnaire is useful for screening, monitoring and measuring the severity of depression. It is responsive to change and is quick to conduct.
Timepoint [1] 325852 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [2] 325853 0
Social-Problem Solving Inventory – Revised (SPSI-R)
The SPSI-R short version consists of 25 questions. It is based on a five-dimensional model of problem solving and provides five scales. Two of the scales measure problem orientation dimensions: positive problem orientation (PO) and negative problem orientation (NO). The remaining three scales are considered problem solving skills scales. These include rational problem solving (RP), impulsivity/carelessness style (IC) and avoidance style (AS).
Timepoint [2] 325853 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [3] 325854 0
Summary of Diabetes Self Care Activities - SDSCA
The 11 item version questions participants about the frequency of self-care activities within the preceding 7 days (0-7) and covers 5 domains; diet, blood glucose testing, exercise, foot care and smoking. Scoring is based on the number of days the self-care behaviour was enacted.
Timepoint [3] 325854 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [4] 325915 0
RetBANK - This is a short-form questionnaire adapted from a comprehensive item bank specifically developed to identify quality of life issues for people with diabetic retinopathy across 9 domains. For this study we will be using a select number of items from 5 domains; activity limitation/mobility (21 items), health concerns (12 items), social (12 items), convenience (10 items) and economic (5 items), an optional domain if the participant is working. Items for each domain were carefully selected according to their content and to ensure that the spectrum of difficulty was represented.
Timepoint [4] 325915 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [5] 325916 0
The Diabetes Quality of Life - Brief clinical inventory (DQL) -
The DQL is based on the Diabetes Quality of Life (DQOL) and has been used in both people with type 1 and 2 diabetes. It features 15 items that cover general diabetes specific QOL areas across 4 domains; impact of treatment, worry about future effects of diabetes, satisfaction with treatment and worry about social/vocational issues. A total score, sum of scores for each item, produces an overall score with the higher the number representing the more positively rated QOL.
Timepoint [5] 325916 0
Data will be collected at baseline, and 3 and 6 months post intervention
Secondary outcome [6] 325917 0
Haemoglobin A1c (HbA1c) - which equates to the average blood glucose measure over the previous 3 months, derived from a blood sample after overnight fasting
Timepoint [6] 325917 0
Data will be collected at baseline, and 3 and 6 months post intervention

Eligibility
Key inclusion criteria
*Type 2 diabetes – on oral medication and/or insulin
*Evidence of diabetic retinopathy
*Self-reported difficulties on the Diabetes Distress Scale (an overall score greater than or equal to 3 indicates distress)
*English speaking
*Able to give written informed consent
*No cognitive impairment as measured by the 6CIT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Type 1 diabetes
*No evidence of diabetic retinopathy
*Self-reported difficulties on the Diabetes Distress Scale (overall score <2.0
*Non-English speaking
*Unable to give written informed consent
*Cognitive impairment as measured by the 6CIT

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/08/2012
Date of last participant enrolment
Anticipated
Actual
18/11/2013
Date of last data collection
Anticipated
Actual
27/02/2014
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6227 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 13644 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 294099 0
Government body
Name [1] 294099 0
Australian Research Council
Country [1] 294099 0
Australia
Primary sponsor type
University
Name
Centre for Eye Research Australia (Department of Ophthalmology, The University of Melbourne)
Address
Level 1
32 Gisborne St
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 292933 0
None
Name [1] 292933 0
Address [1] 292933 0
Country [1] 292933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295514 0
The Royal Victorian Eye and Ear Hospital Human Research & Ethics Committee
Ethics committee address [1] 295514 0
32 Gisborne St
East Melbourne VIC 3002
Ethics committee country [1] 295514 0
Australia
Date submitted for ethics approval [1] 295514 0
21/04/2008
Approval date [1] 295514 0
12/05/2008
Ethics approval number [1] 295514 0
08/815H

Summary
Brief summary
To our knowledge there have been no studies examining problem-solving therapy (PST) specifically in people with diabetic retinopathy (DR), yet from our first study we established that this group face the greatest risk of depression and reduced quality of life (QoL) as well as showing poorer diabetic control compared to those without DR. PST has been shown to be an essential skill for effective diabetes management and effective in reducing diabetes related emotional distress and depressive symptoms. However there is a need for more research that integrates problem-focused and emotion focused interventions in diabetes management.
Addressing diabetes specific distress, stress management and healthy coping, some of the key underlying subjective QoL experiences, may improve glycaemic outcomes. This study also would provide novel research specific to those that have ophthalmological diabetic complications. We propose to adopt a PST designed for primary care that teaches problem solving skills and assists individuals with DR to find practical solutions to vision-related and diabetes-related problems. In doing so we anticipate that participants will adopt a more positive problem solving orientation that will hopefully empower them to subsequently improve their psychological well-being. It has been previously established that developing a problem solving pattern and working through individual solutions assists with perpetuating more positive behavioural habit loops. As a result, this intervention may also have knock on effects in improving diabetes self-management behaviours as this has been shown in previous studies.

Hypothesis
Individuals with diabetic retinopathy who receive tailored problem solving training will show improved quality of life and psychological well-being compared to individuals undergoing usual care.

Aim 1: To develop a tailored, problem solving based program that targets individual quality of life difficulties.

Aim 2: To assess, using a randomised control trial, the effectiveness of this program in improving participants’ quality of life and psychological well-being (reducing diabetes related distress and depressive symptoms).
Investigation will also be undertaken to assess whether enhancing problem solving skills have a direct influence on a participant’s ability to self-manage their diabetes including improving overall glycaemic control and adopting recommended lifestyle practices.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67566 0
Prof Ecosse Lamoureux
Address 67566 0
Centre for Eye Research Australia
Department of Ophthalmology - The University of Melbourne
Level 1 Peter Howson Wing
32 Gisborne St
East Melbourne VIC 3002
Country 67566 0
Australia
Phone 67566 0
+61 3 9929 8067
Fax 67566 0
+61 3 9929 8030
Email 67566 0
[email protected]
Contact person for public queries
Name 67567 0
Dr Gwyn Rees
Address 67567 0
Centre for Eye Research Australia
Department of Ophthalmology - The University of Melbourne
Level 1 Peter Howson Wing
32 Gisborne St
East Melbourne VIC 3002
Country 67567 0
Australia
Phone 67567 0
+61 3 9929 8048
Fax 67567 0
+61 3 9929 8030
Email 67567 0
[email protected]
Contact person for scientific queries
Name 67568 0
Dr Gwyn Rees
Address 67568 0
Centre for Eye Research Australia
Department of Ophthalmology - The University of Melbourne
Level 1 Peter Howson Wing
32 Gisborne St
East Melbourne VIC 3002
Country 67568 0
Australia
Phone 67568 0
+61 3 9929 8048
Fax 67568 0
+61 3 9929 8030
Email 67568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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