Type 2 Diabetes
Conditions
Brief summary
Background In management of type 2 diabetes, autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement. Preliminary evidence has previously shown that the autonomy supporting intervention, guided self-determination method might have effect on HbA1c and diabetes distress in people with type 1 diabetes. However, previous trials were all rated as high risk of bias and did not assess potential harm of the the intervention. Thus, in the current trial, the objective is to investigate the benefits and harms of guided self-determination interventions versus an attention control group intervention in adults with type 2 diabetes. Methods/design The trial planned is a randomised, pragmatic, investigator-initiated, dual-centre, parallel group, clinical superiority trial of guided self-determination intervention versus an attention control group for people diagnosed with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from the department of Endocrinology at a University hospital of Copenhagen, the Capital Region of Denmark and from Steno Diabetes Center Odense, University hospital in the Southern Region of Denmark. The experimental stepped-care intervention will consist of 3-5 analogue or digitally provided guided self-determination sessions lasting up to one hour with a guided self-determination facilitator. The attention control group will receive similar number of sessions lasting up to one hour with a communication trained healthcare professional provided face-to-face, digitally, or over telephone.This trial protocol is guided by the SPIRIT and CONSORT guidelines. Participants will be included if they have type 2 diabetes, \> 18 years old, and, are not pregnant. Participants will be assessed before randomisation, at 5- and 12-months follow-up. The primary follow-up timepoint will be 12-months follow-up. The primary outcome will be diabetes distress. Secondary outcomes will be quality of life, depressive symptoms, and adverse events not considered serious. Exploratory outcome will be glycated haemoglobin, motivation, and serious adverse events. Data will be collected using REDCap. The analyses will be performed using the statistical programme Stata version 16.
Interventions
BEHAVIORALGuided self-determination
Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'…. The goal is registered. Patients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2. A relative may take part in one session completing an analogue reflection sheet as preparation. Participants continue usual care.
BEHAVIORALPersonal support in goal-pursuing
Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'…. The goal is registered. Patients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session. Participants continue usual care.
Sponsors
Odense University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Copenhagen University Hospital, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treatment providers will not be blinded to the allocated trial intervention. The treatment providers are not involved in the analyses. All other medical personnel will be blinded by blinding of notes in the participant's electronic records. Outcome assessors and external statisticians at the Copenhagen Trial Unit will be blinded to the randomisation status of the participants. The statistical analyses will be conducted with the intervention groups coded as X and Y. The steering committee will write two abstracts while the blinding is intact, one assuming the experimental intervention group is X and the control intervention group is Y, and one assuming the opposite. After this, the code will be broken.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* \>18 years of age. * Diagnosed with type 2 diabetes ≥ 3 months according to the International Classification System of Diseases (ICD-11.2-11.9) \[43\]. * Signed informed consent
Exclusion criteria
* Pregnancy * Prior participation in GSD course(s) for the past two years * Lack of signed of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diabetes distress | The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress | Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic Quality of life: SF-36 | SF-36 will be measured at baseline 12-months follow-up. | Generic quality of life assessed by SF-36 The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. |
| Depressive symptoms | Hospital anxiety and depression scale (HADS) will be measured at 12-months follow-up. A higher score on the scale (0-42) indicate higher anxiety and depression | Assessed by the Hospital Anxiety and Depression Scale (HADS) |
| Adverse events not considered serious | 12-months follow-up | Assessed by the Negative Effects questionnaire (NEQ-20) at 12-months follow-up. A higher score (0-80) indicate more adverse events related to the intervention. |
| diabetes distress | Problem areas in diabetes (PAID) will be measured at 5 months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress | Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with one or more serious adverse events in the intervention period | 12-months follow-up | Defined according to the ICH-GCP definition, as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolonging of existing hospitalization and resulted in persistent or significant disability or jeopardized the patient |
| HbA1c | Assessed at baseline and 12-months follow-up. | Assessed from the participants' record. A higher value indicate poorer glycaemic control |
| Type of motivation (autonomous/external), controlled (external) or resigned (amotivated) regarding diabetes self-care practices | Assessed at 12-months follow-up.Autonomous motivation indicated by higher treatment self-regulation Questionnaire (TSRQ)-scores on autonomy (8-56) or autonomy-index (autonomy (8-56) minus control(9-63) or lower TSRQ-scores on amotivation (4-28) | Assessed by the Treatment self-regulation Questionnaire |
Countries
Denmark
Outcome results
None listed