Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05165186

Conditions

Dementia

Dementia Frontotemporal

Dementia Alzheimers

Dementia, Mild

Dementia Moderate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Video Intervention Arm

Study Details

Brief 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.

Conditions

Dementia

Dementia Frontotemporal

Dementia Alzheimers

Dementia, Mild

Dementia Moderate

Study ID

NCT05165186

Start date

Apr 13, 2022

Status verified date

Oct, 2023

Completion date

May 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Exclusion Criteria:

\* Participants who are not able to tolerate or perform the procedures or assessments.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire. [ Time Frame: Baseline and immediately post-intervention ]
  • Change from Baseline in percent correct and in response confidence on Knowledge of Goals of Care Questionnaire. [ Time Frame: Baseline and immediately post-intervention ]
  • Change and Retention of Change in Advanced Care Planning (ACP) Engagement Survey [ Time Frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up ]

Central Contacts and Locations

Central contacts

Amy Marchesano, LMCH

617-726-4587AMARCHESANO@mgh.harvard.edu

Katie Brandt, MM

6176432323katherine.brandt@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Amy Marchesano, LMHC

617-726-4587amarchesano@mgh.harvard.edu

Katie Brandt, MM

6176432323katherine.brandt@mgh.harvard.edu

Principal Investigator:

Brad C Dickerson, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 19, 2023

Last verified

Oct, 2023

Keywords

  • Caregiving
  • Dementia
  • Frontotemporal Dementia (FTD)
  • Caregiver Burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-10-19.