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

NCT02706548 | Completed Phase 1

• 1 other identifier: 15.048
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Adherence; Chronic Disease

Keywords

occupational therapy; medication adherence; intervention studies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Strategies used to manage medications

  4 weeks

Study Arms (2)

Occupational Therapy Intervention Group

EXPERIMENTAL

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

Standard Care Intervention Group

ACTIVE COMPARATOR

Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication.

Behavioral: Standard Care Educational Intervention

Interventions

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.

Occupational Therapy Intervention Group

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.

Standard Care Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant cognitive impairment

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Related Publications (2)

• 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.

  PMID: 26539678 RESULT

• Schwartz JK, Smith RO. Intervention Promoting Medication Adherence: A Randomized, Phase I, Small-N Study. Am J Occup Ther. 2016 Nov/Dec;70(6):7006240010p1-7006240010p11. doi: 10.5014/ajot.2016.021006.

  PMID: 27767947 DERIVED

MeSH Terms

Conditions

Medication Adherence; Chronic Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share