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Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05165186
Study type Interventional
Source Massachusetts General Hospital
Contact Amy Marchesano, LMCH
Phone 617-726-4587
Email AMARCHESANO@mgh.harvard.edu
Status Recruiting
Phase N/A
Start date April 13, 2022
Completion date May 31, 2024

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