Completed

A Tailored Medication Management Intervention for Older Adults

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What is being tested

Medication Management Remote Intervention

+ Waitlist Control

+ Medication Management In-Person Intervention

Behavioral
Who is being recruted

Treatment Adherence and Compliance+3

+ Behavior

+ Patient Acceptance of Health Care

Over 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 19, 2021

Actual date on which the first participant was enrolled.

Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process. Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a "one size fits all" approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered. Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management. We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.

Official TitleA Tailored Medication Management Intervention for Older Adults
NCT04717297
Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceBehaviorPatient Acceptance of Health CarePatient ComplianceHealth BehaviorMedication Adherence

Criteria

3 inclusion criteria required to participate
65 and older

takes 5 or more medications

Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))

2 exclusion criteria prevent from participating
Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more

Lives in institutional setting

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely.

Group II

Sham
The attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person.

Group III

Experimental
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Washington University

St Louis, United StatesOpen Washington University in Google Maps
CompletedOne Study Center