The main study objective is to examine the effect of the PTWD program on glycaemic control of lower-educated participants with T2D. The secondary objectives include the effect on medication use, use of care and T2D self-management behaviours. We…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the DISC-2 study is a 5% decrease in HbA1c in the
intervention group against no decrease in HbA1c in the control group, measured
at 12 months after intervention patients started in the PTWD program.
Secondary outcome
Secondary study outcomes include:
- prescribed T2D medication and use of primary and secondary care
- blood pressure and anthropometrics
- diabetes-related distress, depression and quality of life
- diabetes-related coping behaviors, other health-related behaviors
Background summary
Type 2 diabetes (T2D) is highly prevalent in lower-educated persons. The
Powerful Together With Diabetes (PTWD) program is tailored to the specific
needs of this target group. Our hypothesis is that participation in the program
will improve diabetes self-management behaviours and blood glucose levels in
lower-educated T2D patients.
Study objective
The main study objective is to examine the effect of the PTWD program on
glycaemic control of lower-educated participants with T2D. The secondary
objectives include the effect on medication use, use of care and T2D
self-management behaviours. We also assess conditions for implementation of the
PTWD program in the primary care setting.
Study design
The effect of the program on glycaemic control is evaluated in a
quasi-experimental design, most other outcomes are assessed in observational
studies.
Intervention
On top of usual care, intervention patients participate in the tailored PTWD
diabetes self-management program, including trainer-led group meetings for a
period of 1.5 years. T2D patients in the control group receive primary care as
usual.
Study burden and risks
The burden of the study relates to the intervention condition only. At four
points of time, we measure blood pressure and anthropometrics. Also, a
structured interview is held by a trained interviewer (e.g., T2D self-
management behaviors). Other data for both intervention and control patients
will be collected from the GP information system (HIS) through the Academic
Network of General Practice (ANHA). Physical and physiological discomfort
associated with participation in the DISC-2 study is expected to be negligible.
Participation of lower educated T2D patients is needed because their specific
needs are not being adequately addressed by other diabetes self-management
programs.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
being diagnosed with type 2 diabetes mellitus (T2D) since at least 1 year, aged
> 35 and < 70 years, lower educational level (pre-vocational training at the
highest), in need of more than standard care to support adequate T2D
self-management
Exclusion criteria
- objection against participation from the general practitioner
- a psychiatric disorder which hampers participation in the self-management
program
- being unable to come to the intervention location independently
- planning to stay abroad for a longer time during the intervention period
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79337.018.21 |