NCT07742189

Brief Summary

This study examines the feasibility and acceptability of a brief medication collaboration intervention among older adults (age 60+) with early-stage dementia or mild cognitive impairment who take multiple medications and their family caregivers. The main aims are to: 1) determine the feasibility and acceptability of the intervention for older adults with early-stage dementia and their family caregivers, and 2) explore the effects of intervention on medication collaboration, medication adherence, and beliefs about dementia and autonomy. In this study, participants will: 1) complete a 15-30-minute baseline interview (by Zoom or phone), 2) participate together in a 45-60-minute virtual intervention led by an interventionist that includes: Assessment of medication responsibilities and beliefs. Education about dementia and medication management. Cognitive restructuring to address beliefs about independence and caregiver assistance. Collaborative planning for medication responsibilities and routines; and lastly 3) complete a 15-20-minute one-month follow-up interview (by Zoom or phone) to assess the intervention's acceptability and changes in medication management outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress52%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

July 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 27, 2026

Last Update Submit

August 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the Medication Collaboration Intervention

    Participant-reported acceptability of the intervention will be measured using The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Scale values range from 1 to 5 with a higher score indicating greater perceived acceptability of the Medication Collaboration Intervention.

    1 Month

Secondary Outcomes (5)

  • Medication Collaboration

    1 Month

  • Medication adherence

    1 Month

  • Beliefs about dementia

    1 month

  • Medication Administration Hassles

    1 Month

  • Beliefs about independence with medicines

    1 month

Study Arms (1)

Medication Collaboration Intervention

EXPERIMENTAL

Participants receive a brief virtual medication collaboration intervention designed to support collaborative medication management among older adults with early-stage dementia and their family caregivers. The intervention includes an assessment of medication responsibilities and beliefs, dementia and medication management education, reframing beliefs about autonomy and caregiver assistance, and collaborative development of medication management plans and action planning by setting implementation intentions.

Behavioral: Medication Collaboration Intervention

Interventions

A brief virtual behavioral intervention for older adults with early-stage dementia and their family caregivers designed to support collaborative medication management. The intervention includes: (1) assessment of beliefs about dementia, autonomy, and current medication responsibilities; (2) education on dementia progression and medication management; (3) reframing maladaptive beliefs regarding independence and caregiver assistance; and (4) collaborative development of implementation intentions and medication responsibility plans to facilitate medication adherence and the transition of medication management responsibilities. The intervention is delivered remotely via Zoom or telephone in a single 45-60-minute session by trained study interventionists.

Medication Collaboration Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 or older
  • Diagnosis of dementia, Alzhimer's Disease or Mild Cognitive Impairment
  • Quick Dementia Rating Scale Score 2-12 (inclusive of mild cognitive impairment and mild dementia)
  • Taking 3 or more medications
  • Involved with managing their medications
  • Proficient speaking English
  • Capacity to provide consent
  • Primary family caregiver for the past 3 months
  • Age 18 or older
  • Proficient speaking English

You may not qualify if:

  • adults unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

DementiaMedication Adherence

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 3, 2026

Study Start

August 3, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations