Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence (IMedS)
Primary Purpose
Medication Adherence, Chronic Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Integrative Medication Self Management (IMedS) Intervention
Standard Care Educational Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Medication Adherence focused on measuring occupational therapy, medication adherence, intervention studies
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Occupational Therapy Intervention Group
Standard Care Intervention Group
Arm Description
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.
Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication.
Outcomes
Primary Outcome Measures
Medication Adherence
Daily medication possession ratio via diary
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.
Secondary Outcome Measures
Strategies used to manage medications
Number of new strategies in daily life used to manage medications per participant report
Full Information
NCT ID
NCT02706548
First Posted
March 8, 2016
Last Updated
March 15, 2016
Sponsor
University of Wisconsin, Milwaukee
1. Study Identification
Unique Protocol Identification Number
NCT02706548
Brief Title
Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
Acronym
IMedS
Official Title
Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Chronic Disease
Keywords
occupational therapy, medication adherence, intervention studies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occupational Therapy Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care Intervention Group
Arm Type
Active Comparator
Arm Description
Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Medication Self Management (IMedS) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care Educational Intervention
Intervention Description
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 Outcome Measure Information:
Title
Medication Adherence
Description
Daily medication possession ratio via diary
Time Frame
4 Weeks
Title
Self-perceived improvements in ability to mange medications
Description
Participants at the end of the study indicate if they believe that their ability to manage medications has improved, declined, or stayed the same.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Strategies used to manage medications
Description
Number of new strategies in daily life used to manage medications per participant report
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Single-subject data available in publications
Citations:
PubMed Identifier
26539678
Citation
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.
Results Reference
result
PubMed Identifier
27767947
Citation
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.
Results Reference
derived
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Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
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