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Improving treatment adherence in people with diabetes mellitus (INTENSE)

Towards the development of a personalised E-Health intervention for use in community pharmacies to analyse and improve medication non-adherence in people with type 2 diabetes mellitus, who are non-adherent to oral blood glucose- and/or blood pressure lowering drugs.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21880
Enrollment
300
Registered
2020-07-02
Start date
2020-07-27
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus, medication non-adherence

Interventions

The intervention condition is a personalised intervention program that is based on one or more of the participants’ predefined non-adherence profile(s). The four non-adherence profile(s) are: (I) know

Sponsors

Amsterdam UMC, location VUmc
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactP.J.M. Elders

Amsterdam UMC, location VUmc

p.elders@amsterdamumc.nl020-4448354

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)