Improving treatment adherence in people with diabetes mellitus (INTENSE)
- Conditions
- Type 2 diabetes mellitus, medication non-adherence
- Registration Number
- NL-OMON21880
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
.A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
The main inclusion criteria are:
1)People with type 2 diabetes mellitus treated with oral blood glucose lowering drugs;
2)Non-adherent to oral blood glucose and/or blood pressure lowering drugs;
3)Aged 35-75 years;
4)Mobile phone user.
Exclusion Criteria
The main exclusion criteria are:
1)Use of insulin;
2)People that use medication-intake supporting services provided by the pharmacy;
3)People that suffer from major psychiatric disorders;
4)People that are ‘starters’, meaning that they started using the medicine somewhere in the period in which the dispensing score was calculated;
5)People that are ‘stoppers’, meaning that they did not have a medicine dispatch in the last four months of the period in which the dispensing score was calculated.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure of the study is medication adherence measured with a telephone pillcount. The pillcount will be conducted at baseline and after six months.
- Secondary Outcome Measures
Name Time Method The secondary outcome measures of the study are systolic blood pressure, HbA1c, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, quality of life and medical and productivity costs. Blood pressure and HbA1c level will we obtained using registry data. Data on the other secondary outcome measures will be obtained using questionnaires.