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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Medication Adherence, Chronic Disease

Intervention / Treatment
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* Behavioral: Integrative Medication Self Management (IMedS) Intervention
* Behavioral: Standard Care Educational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occupational Therapy Intervention Group<br>Thirty-minute intervention in which the participant and interventionist discuss past medication taking performance, medication-related goals, and strategies to meet goals. Intervention is enhanced with motivational interviewing and therapeutic use of self. | Behavioral: Integrative Medication Self Management (IMedS) Intervention<br>* Half of participants received a manualized 30-minute occupational therapy intervention, Integrative Medication Self-Management Intervention (IMedS). During IMedS, the interventionist and client progress through three steps in which the pair: 1) reflect on past performance of medication management, 2) set a medication goal, and 3) generate strategies to reach the goal. During strategy generation, the interventionist uses therapeutic use of self and motivational interviewing to help the client self-generate new medication management strategies, specifically addressing 1) altering the activity, 2) advocacy, 3) education, 4) assistive technology, 5) environmental modifications, and 6) securing timely refills.<br>|
| Active Comparator: Standard Care Intervention Group<br>Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication. | Behavioral: Standard Care Educational Intervention<br>* The standard care educational intervention was a 30-minute pamphlet based educational session. In the standard care intervention group, participants and interventionist first reviewed the pamphlet, Managing Your Medicines: Our Guide to Effective Medication Management (American Heart Association & American Stroke Association, 2013). Then, the interventionist engaged in active listening, where she asked open-ended questions about the participant's medication routines and provided simple reflections. For the standard care procedures, the interventionist was prohibited from providing affirmations, complex reflections, summaries, problem-solving, or suggesting any specific interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strategies used to manage medications | Number of new strategies in daily life used to manage medications per participant report | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occupational therapy, medication adherence, intervention studies