- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165186
Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amy Marchesano, LMCH
- Phone Number: 617-726-4587
- Email: AMARCHESANO@mgh.harvard.edu
Study Contact Backup
- Name: Katie Brandt, MM
- Phone Number: 6176432323
- Email: katherine.brandt@mgh.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Katie Brandt, MM
- Phone Number: 6176432323
- Email: katherine.brandt@mgh.harvard.edu
-
Contact:
- Amy Marchesano, LMHC
- Phone Number: 617-726-4587
- Email: amarchesano@mgh.harvard.edu
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Principal Investigator:
- Brad C Dickerson, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire.
Time Frame: Baseline and immediately post-intervention
|
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.
Time Frame: Baseline and immediately post-intervention
|
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
Time Frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change and Retention of Change in Decisional Conflict Scale
Time Frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up
|
The Decisional Conflict Scale is a validated, self-reported instrument assessing 5 dimensions of decision-making feelings (uncertain, uninformed, unclear about values, unsupported; ineffective decision making). Possible scores range from 1 (strongly disagree) to 5 (strongly agree). 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
|
Response Rate and Retention of Response Rate for Limited Medical Care and Comfort Care
Time Frame: Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up
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The ACP Preferences Survey is a self-reported instrument asking a one multiple choice question with 3 options; Life Prolonging Care, Limited Medical Care and Comfort Care. Change = (Post intervention response rate - baseline response rate) Retention = (3 Month Follow Up response rate - Post Intervention response rate) Retention = (6 Month Follow Up response rate - Post Intervention response rate) |
Baseline and immediately post-intervention Post-intervention and 3 Month Follow Up Post Intervention and 6 Month Follow Up
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Response Rate for Advanced Care Planning (ACP) Documents Survey
Time Frame: Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up
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The ACP Documents Survey is a self-reported instrument asking 3 yes/no/unsure questions assessing the completion of ACP documents with a total possible score of 3 (1 point for each yes answer). A higher score indicates a higher amount of documents completed. Change = (3 month follow up score - baseline score) Change = (6 month follow up score - baseline score) |
Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up
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Response Rate of Satisfaction Survey on Video Rating Survey post-intervention
Time Frame: Immediately post-intervention
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Responses from the Video Rating Survey, a self-reported instrument asking 5 questions assessing perception of ACP Video: Goals of Care: Advanced Dementia.
Possible scores range from 1 (strongly disagree) to 5 (strongly agree) for knowledge, comfort, desire to learn more and recommend to others with a higher summary score indicating a positive response except for comfort, where a higher response indicating more discomfort.
Importance to learn about this topic was measured on a 5-point scale; 1 (Not at all important) to 5 (Very Important) with a higher summary score indicating higher importance.
|
Immediately post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline self-report measure of affect to post intervention self-report measure of affect
Time Frame: Baseline and immediately post-intervention
|
The PANAS is a validated self-report instrument assessing affect. Possible answers range from 1 (Very slightly or not at all) to 5 (Extremely) The total score is calculated by finding the sum of the 10 positive items and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect. Change = (Post-intervention - Baseline) |
Baseline and immediately post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brad C Dickerson, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Stress, Psychological
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Alzheimer Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Caregiver Burden
Other Study ID Numbers
- 2021P001869
- 5R01AG061968-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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