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

Chronic Disease Clinical Trial

— IMedS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706548
• Other study ID #: 15.048
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2016
• Last updated: March 15, 2016
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Medication Adherence

Intervention

Behavioral:
• Integrative Medication Self Management (IMedS) Intervention
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

References & Publications (1)

Schwartz JK, Smith RO. Benefits of Student Engagement in Intervention Research. Am J Occup Ther. 2015 Sep-Oct;69 Suppl 2:6912185050p1-6912185050p10. doi: 10.5014/ajot.2015.018200. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Daily medication possession ratio via diary	4 Weeks	No
Primary	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	No
Secondary	Strategies used to manage medications	Number of new strategies in daily life used to manage medications per participant report	4 weeks	No