Motivational Interviewing (MI) Intervention to Improve Adherence
MI
A Motivational Interviewing Intervention Customized by Patient Adherence Patterns
2 other identifiers
interventional
727
1 country
1
Brief Summary
The purpose of this study is to examine the effectiveness of a telephone motivational interviewing intervention by pharmacy students in enhancing adherence to angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) (ACE/ARBs) among patients with diabetes and hypertension in a Medicare advantage plan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2019
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2019
CompletedFirst Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedResults Posted
Study results publicly available
June 15, 2023
CompletedJune 15, 2023
May 1, 2023
1.8 years
June 10, 2019
January 31, 2023
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence Measure
Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
12 months following initial call
Study Arms (2)
Motivational interviewing intervention arm
EXPERIMENTALThe intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Control
NO INTERVENTIONusual care
Interventions
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Eligibility Criteria
You may qualify if:
- Continuous enrollment over the study period July 2016 to December 2018.
- A prescription filled for an ACEI or ARB medication between July 1st, 2017- December 31st, 2017. This will be defined as the index date (for phase 1).
- Diagnosis of both DM and HTN prior to index date, identified through the health plan's medical claims program (CCMS) using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes only.
You may not qualify if:
- Disenrollment from drug plan.
- Death prior to end of the study.
- Having a diagnosis of dementia in the one-year pre-index period.
- Having an ACEI/ARB contraindication like angioedema, hyperkalemia, and renal artery stenosis in the one-year pre-index period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Omar Serna
Houston, Texas, 70092, United States
Related Publications (1)
Mohan A, Majd Z, Johnson ML, Essien EJ, Barner J, Serna O, Gallardo E, Fleming ML, Ordonez N, Holstad MM, Abughosh SM. A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes. Drugs Aging. 2023 Apr;40(4):377-390. doi: 10.1007/s40266-023-01008-6. Epub 2023 Feb 27.
PMID: 36847995DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
While the initial plan for the intervention was to have monthly follow-up calls, due to the COVID-19 pandemic, there were gaps in the intervention, which could have affected the results.
Results Point of Contact
- Title
- Susan Abughosh
- Organization
- University of Houston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 13, 2019
Study Start
May 29, 2019
Primary Completion
March 22, 2021
Study Completion
March 22, 2022
Last Updated
June 15, 2023
Results First Posted
June 15, 2023
Record last verified: 2023-05