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.

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. - Improving treatment adherence in people with diabetes mellitus (INTENSE)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55758

Enrollment

150

Registered

2018-06-20

Start date

2020-10-09

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

diabetes Type 2 diabetes mellitus

Interventions

The trial consists of an intervention and control condition. The intervention condition is a personalised intervention, which consists of four supporting programs. Participants will receive supporti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - People with type 2 diabetes mellitus that are non-adherent to oral blood glucose and/or bloodpressure lowering drugs. - Participants aged 35-75 years. - Mobile phone user.

Exclusion criteria

Exclusion criteria: - People in which adherence data is invalid for instance due to hospital admission. - People that use medication-intake supporting pill packaging services provided by the pharmacy. - People that suffer from major psychiatric disorders. - People that are *starters*, meaning that they started using the medicine somewhere in the period in which the dispensing score was calculated. - 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

Measure	Time frame
The primary study outcome is medication adherence (measured with change in a telephone pill count).	—

Secondary

Measure	Time frame
The secondary study parameters are: - Systolic blood pressure (registry data) - HbA1c (registry data) - Medication adherence (MARS-5 questionnaire) - Attitude and beliefs toward medication (BMQ specific questionnaire) - Satisfaction with diabetes treatment (DTSQs+c questionnaire) - Quality of life (EQ-5D-5L questionnaire) - Medical and productivity costs (iMTA costs questionnaire) The other study parameters are: - Barriers and facilitators that people with type 2 diabetes and pharmacists experience in the use of the intervention. - Refinement of the non-adherence profiling algorithm after evaluation of the intervention.	—

Measure

Time frame

The secondary study parameters are: - Systolic blood pressure (registry data) - HbA1c (registry data) - Medication adherence (MARS-5 questionnaire) - Attitude and beliefs toward medication (BMQ specific questionnaire) - Satisfaction with diabetes treatment (DTSQs+c questionnaire) - Quality of life (EQ-5D-5L questionnaire) - Medical and productivity costs (iMTA costs questionnaire) The other study parameters are: - Barriers and facilitators that people with type 2 diabetes and pharmacists experience in the use of the intervention. - Refinement of the non-adherence profiling algorithm after evaluation of the intervention.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)