|- candidate number||15098|
|- NTR Number||NTR4064|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2013|
|- Secondary IDs|| WC2012-056. Wetenschapscommissie|
|- Public Title||Effects of online self-management support for type 2 diabetes with and without coaching: A randomized controlled trial, nested in an observational cohort study in primary diabetes care|
|- Scientific Title||Effects of online self-management support for type 2 diabetes with and without coaching: A randomized controlled trial, nested in an observational cohort study in primary diabetes care|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-apr-2015|
|- Target number of participants||220|
|- Interventions||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.|
|- 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. |
|- Timepoints||Participants will be followed for one year and will have a follow-up measurements at 3,6 and 12 months.|
|- Trial web site||http://www.e-vita.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Vugt, van|
|- CONTACT for SCIENTIFIC QUERIES|| Vugt, van|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Stichting Zorg Binnen Bereik|
|- Brief 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.
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.
|- Main changes (audit trail)|
|- RECORD||8-jul-2013 - 21-jul-2013|