depressive symptoms diabetes-specific distress
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Both the intervention group as the control group consist of - type 2 diabetes mellitus patients, - who receive regular diabetes care from the POH in the general practice, - and have moderate or severe problems of daily functioning (=4 Distress Screener DS).
Exclusion criteria
Exclusion criteria: No exclusion criteria. We will send the short questionnaire to all patients who consecutively will visit their POH for a regular diabetes check-up within the next two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect evaluation The primary outcome of the RCT is perceived daily functioning, measured by means of a VAS-scale (DFT). Cost-effectiveness evaluation The cost-effectiveness evaluation includes program costs of implementing SMS, costs of training, direct health care costs, direct non health care costs and indirect costs (production losses relating to both paid and unpaid work, measured by SF-HLQ). Process evaluation Questionnaires completed by the practice nurse and patients will enable construction of several composite variables like the proportion of patients receiving the intervention as intended, the proportion of patients who refused and their reasons, and patients* ability to understand and implement the intervention. Interviews and focus groups with patients, practice nurses and GPs will provide insight into experiences and satisfaction with SMS, obstacles to administering SMS and possible solutions for large scale implementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Autonomy and Participation 2. Satisfaction with care 3. Quality of life 4. Disease-specific quality of life 5. Self-efficacy 6. Glycaemic control Demographic factors are age and gender of the POH and type of practice (solo, duo, group). Patient demographics are age, gender, marital status, income, education, year of diagnosis. The 4DSQ during follow up (at T3 and T12) gives insight in mental health problems. | — |
Countries
Netherlands