Health TrialsbyHealthPanel

Feasibility of a Dyadic Music-based Intervention for Persons Living With Dementia and Their Care Partners

ConditionDementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University

About this trial

This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 60 and older

Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent.

Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship (score of 3 or less on the relationship satisfaction measure), given that one member's dissatisfaction affects the other.

Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia medications or opioids in the past 60 days to minimize the confounding effects of medications.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dyadic Music-based Intervention (MBI)

    Behavioral

    The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.

  • Reminiscence Activity

    Behavioral

    The control condition intends to isolate the impact of music in the dyadic MBI and will consist of an object-based reminiscence activity shared by the dyad. The duration, dose, frequency, and timing in the control condition will match that of the intervention group.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Persons Living With Dementia (PLWD) - Caregiver DyadsExperimental treatment 1 intervention
Group B: Reminiscence activityPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of dyads who complete at least 4 out of 6 music/control condition sessions

Time frame
Up to the end of treatment, 6 weeks
2

Percentage of dyads who rate the music/control condition sessions after intervention as highly acceptable/satisfactory (the average score is greater than 3)

Researchers will evaluate the acceptability of each condition using the Acceptability of Intervention Measure (AIM). The AIM has 4 statements on a 5-point Likert scale, on which responses range from 1=completely disagree to 5=completely agree.

Time frame
Up to the end of treatment, 6 weeks

Secondary outcomes

1

Reasons for dyad drop out

The reason why the dyad decided to drop out will be documented

Time frame
Up to the end of treatment, 6 weeks
2

Number of dyads screened per month

Recruitment will be assessed as number of dyads screened per month

Time frame
Through study completion, an average of 1 year
3

Number of dyads enrolled per month

Time frame
Through study completion, an average of 1 year
4

Percentage of eligible dyads who enroll

Enrollment success will be calculated as percent of eligible dyads who enroll

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov

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