Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2024-05-31

Brief Summary

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The overall objective of this study is to compare knowledge, decisional conflict, preferences, and caregiver burden over time caregivers of Alzheimer's Disease and Related Dementias (ADRD) patients by comparing the effectiveness of a video decision aid intervention and enhanced usual care.

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Detailed Description

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The investigators will conduct a randomized controlled trial in 150 caregivers of patients with ADRD, who will be randomized to either the video (intervention) or enhanced usual care (informational sheet, control). The intervention group will use the suite of video decision aids. Caregivers in the control group will review the informational sheet, which covers the same information.

Data collection is estimated to take no longer than an hour and will be conducted after the scheduled visit at the Massachusetts General Hospital Memory Disorders Unit (MGH MDU) clinic. The relatively brief interviewing time (30 minutes) in which the survey is conducted should assure completion of the interview without burdening participants. The investigators do not foresee the additional time to complete the survey to be a barrier to successful recruitment and completion of the protocol. Participants will be provided written copies of the questions in order to follow along during the face-to-face interviews.

The research assistant (RA) will collect baseline data, randomize caregivers to either the video or control arm via concealed envelopes, and administer the intervention. After this baseline interview and randomization, the RA will collect the remaining outcomes data regarding knowledge, preferences, decisional uncertainty, and caregiver burden from the caregiver. For those participants randomized to the video intervention, they will also be asked questions regarding the usefulness of the video and their comfort with the video. All caregivers will be given a website link to access the videos shown from their home. As the investigators have done in prior studies, the investigators will contact by telephone caregivers at 3 and 6 months to assess their caregiver burden at that time. Fidelity of the video intervention during the in-person survey and remotely at home will be tracked via a video website link that documents show-rates (date and time video accessed) as well as play-through rates (was the video watched to completion).

Conditions

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Dementia Dementia Frontotemporal Dementia Alzheimers Dementia, Mild Dementia Moderate Dementia Severe Caregiver Burnout Caregiver Stress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Video Intervention Arm

For participants randomized to the video intervention arm, participants will be shown two videos about Advanced Care Planning, and then they will be asked questions regarding the usefulness of the video and their comfort with the video

Group Type EXPERIMENTAL

Video Intervention Arm

Intervention Type OTHER

For participants randomized to the video intervention arm, participants will be shown two videos about Advanced Care Planning, and then they will be asked questions regarding the usefulness of the video and their comfort with the video.

Control Arm

For participants randomized to the control group arm, participants will review an informational sheet, which covers the same information as the videos shown to the intervention arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Video Intervention Arm

For participants randomized to the video intervention arm, participants will be shown two videos about Advanced Care Planning, and then they will be asked questions regarding the usefulness of the video and their comfort with the video.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All participants must be age 18 or older.
* Participants must be able to speak and understand English.
* Participants must be a caregiver of someone with Alzheimer's Disease, frontotemporal dementia, or a related dementia
* Participants should be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations.