type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Type 2 diabetes mellitus treated by insulin therapy. * BMI >
Exclusion criteria
Exclusion criteria: * Recent ( 170 mmHg and/or DBP > 100 mmHg, 2 out of 3 measurements) * Any chronic disease other than type 2 diabetes hampering participation (at the discretion of the investigator) * Low motivation to participate (score 2 *weak* or 1 *very weak* on a 5-point scale). * Alcohol consumption of more than 28 units per week, and no intentions of moderation. * Psychiatric disease (as defined by DSM-V)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective 1: implementation and integration in first line health care setting * Lessons learned from GP and PA experiences: regarding their preferences and user needs. * Lessons learned for future implementation in general practice: fit within diabetes *ketenzorg* processes, number of patients approached and number of patients entering the program and number of and reasons for patients leaving the program. * Lessons regarding user needs and design requirements (infrastructure, architecture, security) for future digital reporting to participating GP*s (General Practitioners) and their PA*s (Physician Assistants) about effects of the intervention and progress achieved, to be used in regular care in order to reach sustainability of behavioral change. The research team will conduct brief telephone interviews with GP and PA after two weeks (together with the telephone based briefing of patient progress) regarding user needs and design requirements for future digital reporting and regarding implementation barriers and facilitations for implementation of the intervention in regular care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective 2: effect of the intervention * Impacts on healthy lifestyle behaviors, measured with BRAVO [standardized survey], on Health Related Quality of Life [RAND SF-8 survey] and exercise capability (aerobic & resistance/strength tests). Progress reports of outcomes of the intervention on behaviors and effects will be provided to GP and PA after 2 weeks and at the 10-week out-take coach session. * Fasting plasma glucose, HbA1C, total cholesterol, HDL cholesterol and triglyceride levels, blood pressure, BMI [as monitored within standard first line diabetes-2 care] * Medication requirements (insulin, metformin, statins, antihypertensives) | — |
Countries
The Netherlands