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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20746

Enrollment

220

Registered

2013-07-08

Start date

2013-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM)

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,

Eligibility

Inclusion criteria

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: 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 outcomes

Primary

Measure	Time frame
Our ambition is to improve the self-care activities measured with the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactVugt, van

Van der Boechorststraat 7 MF-D345,

m.vanvugt@vumc.nl0204446099

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)