Home-based Monitoring & Enabled Medication Independence With New Digital Tools

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Michigan

About this trial

This clinical trial is studying an online tool that may help older adults safely manage their medications at home. The study focuses on older adults who live alone and have memory concerns or mild changes in thinking. Many people in this group take several medications, which can make it hard to keep track of when and how to take them, notice side effects, or know when to ask for help.

In this study, participants use an online self-monitoring platform to record any problems, symptoms, or concerns they have while taking their medications. The platform also provides helpful education and suggestions for managing medications and symptoms. Participants can share summaries from the platform with their health care team, which may help improve communication and support.

The goal of the study is to see whether this tool can help older adults feel more confident, informed, and prepared to manage their medications safely while living at home.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Older adults (≥ 65 years old)

Living alone (residing in a single-family home, apartment, or independent senior housing unit with no other co-habitating adults or children; and having been living alone continuously for at least 6 months prior to screening)

With subjective or mild cognitive decline (a screening test to confirm)

Taking at least five prescribed medications concurrently

Disqualifiers

Having severe cognitive, vision, hearing, or other impairment

Unable to use computers or mobile devices

Relying on someone else to manage medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • HOME-MIND

    Behavioral

    HOME-MIND aims to improve medication self-management and reduce perceived medication burden in older adults living alone with subjective or mild cognitive decline. This 3-month intervention includes daily technology-enabled self-monitoring of medication safety events or experiences, personalized educational support informed by self-monitoring data, visualizations and summaries of self-monitoring data on a personal dashboard, and sharing self-monitoring summaries with health care providers to facilitate health communication.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: HOME-MINDExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Medication self-management

Medication self-management is defined as "the extent to which a patient takes medication as prescribed, including not only the correct dose, frequency and spacing, but also its continued, safe use over time". It is deconstructed into a series of steps a patient must take to safely and effectively take their medications, including filling a prescription, understanding directions for use, organizing a regimen, taking medications, monitoring side effects, and sustaining use over time. In this study, we will measure medication self-management using the 12-item Measure of Drug Self-Management. This tool uses a sum of scores ranging from 0 (poor medication self-management) to 12 (adequate medication self-management). The tool can also be used to categorize patients as having "adequate" drug self-management skills (score of 10 or greater) or "inadequate" drug self-management skills (score of less than 10).

Time frame
From enrollment to the end of the study at 3 months, including monthly assessments.

Secondary outcomes

1

Medication burden

Assessing patient-perceived medication burden is the first step in medication optimization and evaluates how complex dosing regimens, side effects, out-of-pocket costs, and daily lifestyle disruptions affect a patient's quality of life, helping determine patients' attitudes toward and experiences with medications. In this study, perceived medication burden is measured using the 41-item Living with Medicines Questionnaire Version 3 (LMQ-3), which includes eight domains: relationships with health professionals, practicalities, interferences, effectiveness, side effects, concerns, cost, and autonomy. Total/composite scores for Likert-type statements range from 41 to 205; higher scores indicate worse experiences of medicine use (higher medicine burden). Additionally, total scores can be categorized as: No burden at all (41-73); Minimal burden (74-106); Moderate burden (107-139); High burden (140-172); and Extremely high burden (173-205).

Time frame
From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.

Other outcomes

1

Patient activation

Patient activation refers to an individual's confidence, knowledge, motivation, and skills needed to manage their own health and healthcare, as measured by the 13-item Patient Activation Measure (PAM). Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.

Time frame
From enrollment to the end of the study at 3 months, including monthly assessments.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Arizona State University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: