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

NCT05165186 | Unknown

• 2 other identifiers: 2021P0018695R01AG061968-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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; Dementia Severe; Caregiver Burnout; Caregiver Stress Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire.

  The Knowledge of Advanced Dementia Questionnaire is a verbally administered self-reported instrument assessing knowledge with six true/false questions with a total possible score of 6 (1 point for each correct T/F), with high scores indicating better knowledge. A confidence rating scale with possible scores from 1 (not at all confident) to 5 (extremely confident). Change = (post Knowledge score - pre Knowledge score) Change = (post Confidence score - pre Confidence score)

  Baseline and immediately post-intervention

• Change from Baseline in percent correct and in response confidence on Knowledge of Goals of Care Questionnaire.

  The Knowledge of Goals of Care is a verbally administered self-reported instrument assessing knowledge with six true/false questions with a total possible score of 6 (1 point for each correct T/F), with high scores indicating better knowledge. A confidence rating scale with possible scores from 1 (not at all confident) to 5 (extremely confident). Change = (post Knowledge score - pre Knowledge score) Change = (post Confidence score - pre Confidence score)

  Baseline and immediately post-intervention

• Change and Retention of Change in Advanced Care Planning (ACP) Engagement Survey

  The ACP Engagement Survey is a self-reported instrument assessing confidence and readiness for ACP activities. Possible scores range from 1 (Not at all) to 5 (Extremely). Change = (Post intervention score - baseline score) Retention = (3 Month Follow Up - Post Intervention) Retention = (6 Month Follow Up - Post Intervention)

  Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

Secondary Outcomes (4)

• Change and Retention of Change in Decisional Conflict Scale

  Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

• Response Rate and Retention of Response Rate for Limited Medical Care and Comfort Care

  Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up

• Response Rate for Advanced Care Planning (ACP) Documents Survey

  Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up

• Response Rate of Satisfaction Survey on Video Rating Survey post-intervention

  Immediately post-intervention

Other Outcomes (1)

• Change from Baseline self-report measure of affect to post intervention self-report measure of affect

  Baseline and immediately post-intervention

Study Arms (2)

Video Intervention Arm

EXPERIMENTAL

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

Other: Video Intervention Arm

Control Arm

NO INTERVENTION

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 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.

Video Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Pick Disease of the Brain; Alzheimer Disease; Lymphoma, Follicular; Caregiver Burden; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; Tauopathies; Neurodegenerative Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Brad C Dickerson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Marchesano, LMCH

CONTACT

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

Katie Brandt, MM

CONTACT

6176432323; katherine.brandt@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Frontotemporal Disorders Unit and Laboratory of Neuroimaging, Massachusetts General Hospital

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: April 13, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of article
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)