Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence

Phase 1

Completed

• Conditions: Medication Adherence; Chronic Disease

• Registration Number: NCT02706548
• Lead Sponsor: University of Wisconsin, Milwaukee

Brief Summary

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Unfortunately, current interventions for medication nonadherence are not very effective. This objective of this study is to test a new intervention, the Integrative Medication Self-management (IMedS) intervention to improve medication adherence in adults with chronic health conditions.

Detailed Description

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Objective: The purpose of this study was to perform a phase I feasibility study to understand if an integrated occupational therapy intervention could help people with chronic health conditions improve their adherence to medications. Method: Using a small-N design, we report single-subject analyses of the medication adherence, behavior counts, and perceptions of medication adherence of participants before and after either an occupational therapy intervention or standard of care intervention. We used a multiple baseline approach with inter-subject replication, and blinding.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-03
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-11
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Diagnosed with a chronic health condition
• Live in the community
• A medication regimen of 5 or more medications a day recommended by a health care professional
• Independently manage medications
• Difficulty taking medications as prescribed
• Live in the Milwaukee area

Exclusion Criteria

• Significant cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence	4 Weeks	Daily medication possession ratio via diary
Self-perceived improvements in ability to mange medications	4 weeks	Participants at the end of the study indicate if they believe that their ability to manage medications has improved, declined, or stayed the same.

Secondary Outcome Measures

Name	Time	Method
Strategies used to manage medications	4 weeks	Number of new strategies in daily life used to manage medications per participant report