Background
Methods
Objectives
Study design
Ethical approval
Study context and population
Sample size calculation
Enrolment of participants
Usual care: the diabetes self management education programme
Intervention
Data collection
Variable | Instrument | Data collection method | |
---|---|---|---|
Health outcome indicators
| |||
HbA1C | DCA Vantage (Siemens) | Blood samples taken by trained field researchers, analysed by laboratory staff at location. Results on a patient record form | |
Blood pressure | Electronic sphygmomanometer from certified manufacturer, study Standard Operating Procedure (SOP) | By trained field researchers, on patient record form | |
BMI | Height and weight measured by research staff, study SOP | By trained field researchers, on patient record form | |
Waist/Hip ratio | Conventional measuring tape according to study-SOP | By trained field researchers, on patient record form | |
Diabetic foot lesions (nr) | Number of active wounds on both feet, detected through systematic examination by trained research staff | By trained field researchers, on patient record form | |
Access to care indicators
| |||
Attendance of DSME and medical care | Self-report over 12-month period: number of educator-contacts (check DSME patient records), visits to medical doctor, kidney-function test | Interviews with paper questionnaire, by researchers (Q28, 30, 31) | |
Total medical expenditure | Self-report | Interviews with paper questionnaire, by researchers (Q32 a+b) | |
Total time for h care visits | Self-report | Interviews with paper questionnaire, by researchers ( Q32c+d) | |
Quality of support indicators
| |||
Perceived Quality of Care DSME | PACIC score (Glasgow et al. [33]) | Interviews with paper questionnaire, by researchers (Q33a-t) | |
DSME needs and services | 6-elements questionnaire, inspired by Diabetes Care Profile [34] | Interviews with paper questionnaire, by researchers (Q34+35) | |
Enablement through DSME | Patient enablement score [35] | Interviews with paper questionnaire, by researchers (Q36) | |
Empowerment indicators
| |||
Level of knowledge on diabetes (care) | Interviews with paper questionnaire, by researchers (Q13) | ||
Attitude towards diabetes | Attitude scale Diabetes Care Profile [34] | Interviews with paper questionnaire, by researchers (Q14) | |
Feeling of control | Control scale from Diabetes Care Profile [34] | Interviews with paper questionnaire, by researchers (Q15a-d) | |
Self-management behaviour
| |||
Adherence to glucose monitoring & control | Self-report of last time self-monitoring, professional monitoring, medication taking | Interviews with paper questionnaire, by researchers (Q16-25) | |
Adherence to exercise & diet | Self-report | Interviews with paper questionnaire, by researchers (Q38/37, 41) | |
Process indicators
| |||
Number of SMS sent (ProjIC) to participant | Database that is used to send out ProjIC | Assessment by the project manager | |
Number and type (call or SMS) of PatIC to educators | Telephone provider records | Assessment by the project manager | |
intervention cost at DSMS programme level | Extraction from data from project documents | Collected by country research team | |
Context characteristics
| |||
Diabetes prevalence, phone penetration, literacy rate, DSME programme characteristics | extraction from data from project documents, country-related publications and other secondary data | Collected by country research team | |
Knowledge and professional habits of diabetes care providers | Provider Profile, Diabetes Management Practices and Brief Diabetes Knowledge & Practice Test (adapted from ([38]) | Written self-administered questionnaire to health providers |