No registrations found.
ID
Source
Brief title
Health condition
Type 2 diabetes mellitus (T2DM)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our ambition is to improve the self-care activities measured with the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Secondary outcome
Symptoms of diabetes-distress will be assessed using the Problem Areas In Diabetes care (PAID) survey, 5-item version. The five items (WHO-Five) questionnaire covers positive mood, vitality and general interests. Health-related Quality of Life (HRQoL) is tested by using the EQ-5D questionnaire.
Background summary
Background
Every year the number of people with T2DM in the Netherlands increases. However the number of care providers is not growing accordingly. To keep health care available and affordable, a shift in patient treatment is necessary. A web-based self-management program has the potential of supporting T2DM patients with managing their diabetes and reducing the workload for the care provider. This study aims to test the effectiveness of online coaching within a web-based self-management program.
Research design and methods
The effects of a web-based self-management program including coaching will be tested with a nested randomized controlled trial within a healthcare group of the region Drenthe in the Netherlands. For one year 220 T2DM patients will be randomized in to an intervention group (n=110) or a control group (n=110). The intervention group will receive the online self-management program including online coaching. The control group will receive only the online self-management program. Participants will be followed for one year and will have a follow-up measurements at 3,6 and 12 months.
Discussion
The intervention being tested is set to support T2DM patients with their disease self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcome measures. When proven effective this self-management support program could be offered to other health care groups and their T2DM patients in the Netherlands.
Study objective
We aim to test the hypotheses that offering additional online adaptive coaching to a web-based self-management program will be more effective than a web-based self-management program without coaching in terms of self-management behaviour without being at the expense of diabetes distress, quality of life, satisfaction with care and metabolic outcomes. We hypothesize that the self-management behaviour and biomedical outcomes will be significant better in the group with online adaptive coaching versus those who don¡¯t receive additional adaptive coaching.
Study design
Participants will be followed for one year and will have a follow-up measurements at 3,6 and 12 months.
Intervention
110 randomized patients receive additional online coaching who provide feedback on the behaviour goals, action plans and evaluation of the executed health behaviours. The coaches serve as facilitator, and focus on process and are instructed to let the patient think for themselves.
Vugt, van
Amsterdam 1081 BT
The Netherlands
0204446099
m.vanvugt@vumc.nl
Vugt, van
Amsterdam 1081 BT
The Netherlands
0204446099
m.vanvugt@vumc.nl
Inclusion criteria
The sample consists of people with type 2 diabetes mellitus (T2DM) who are treated in primary health care in the Drenthe region of the Netherlands. The available sample pool consists of approximately 18.500 T2DM patients.
Inclusion criteria are A diagnosis of type 2 diabetes mellitus, as registered in the primary care system under the diagnosis T90.2, and where the GP is defined as the main care giver; and aged ¡Ý18 years.
Exclusion criteria
Exclusion criteria for the RCT are: Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
Insufficient knowledge of the Dutch language to understand the requirements of the study and/ or the questions posed in the questionnaires. Life expectancy <1 year due to malignancies or other terminal illnesses. Cognitive impairment, including dementia, which interferes with trial participation. Any condition that the Investigator and/or coordinating Investigator feel would interfere with trial participation or evaluation of results.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3902 |
| NTR-old | NTR4064 |
| Other | Wetenschapscommissie : WC2012-056. |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |