ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

DMP_INT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetic retinopathy

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Eye

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]

Behaviour

Intervention code [2]

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]

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]