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Completed

NCT Number: NCT02706548

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative Medication Self Management (IMedS) Intervention

Behavioral

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.

Standard Care Educational Intervention

Behavioral

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.

Primary outcomes

  1. Medication Adherence

    Time frame: 4 Weeks

    Daily medication possession ratio via diary

  2. Self-perceived improvements in ability to mange medications

    Time frame: 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 outcomes

  1. Strategies used to manage medications

    Time frame: 4 weeks

    Number of new strategies in daily life used to manage medications per participant report

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Registry information

Acronym: IMedS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2016
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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