DementiaNCT05165186
Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions
A study testing Video Intervention Arm in people with Dementia and Dementia Frontotemporal, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia Frontotemporal, Dementia Alzheimers
- What is being tested?
- Video Intervention Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who are not able to tolerate or perform the procedures or assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Amy Marchesano, LMHC, 617-726-4587, amarchesano@mgh.harvard.edu
Katie Brandt, MM, 6176432323, katherine.brandt@mgh.harvard.edu
About this study
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.
Read the 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).
- Conditions
- Dementia, Dementia Frontotemporal, Dementia Alzheimers, Dementia, Mild, Dementia Moderate, Dementia Severe
- Being tested
- Video Intervention Arm
- Keywords
- Caregiving, Dementia, Frontotemporal Dementia (FTD), Caregiver Burden
- Medical subject headings
- Dementia, Pick Disease of the Brain, Alzheimer Disease, Lymphoma, Follicular, Caregiver Burden, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Intervention ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up
Response Rate of Satisfaction Survey on Video Rating Survey post-intervention
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start13 Apr 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Bradford Clark Dickerson, M.D., Massachusetts General Hospital
- Investigators
- Brad C Dickerson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165186
- Sponsor's protocol ID
- 2021P001869
- Other IDs
- 5R01AG061968-03
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share individual participant data that underlie the results reported in each published article, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions
- ClinicalTrials.gov ID
- NCT05165186
- Acronym / sponsor ID
- 2021P001869
- Conditions
- Dementia, Dementia Frontotemporal, Dementia Alzheimers, Dementia, Mild, Dementia Moderate, Dementia Severe
- Keywords
- Caregiving, Dementia, Frontotemporal Dementia (FTD), Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Intervention Arm | Experimental | Other: Video Intervention ArmFor 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are not able to tolerate or perform the procedures or assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Intervention ArmFor 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 |
Primary outcome
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)
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)
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)
4 secondary outcomes
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
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
Response Rate for Advanced Care Planning (ACP) Documents Survey
Time frame: Baseline and Month 3 Follow Up Baseline and Month 6 Follow Up
Response Rate of Satisfaction Survey on Video Rating Survey post-intervention
Time frame: Immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. We will share individual participant data that underlie the results reported in each published article, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad C Dickerson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Intervention Arm in people with Dementia and Dementia Frontotemporal, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Marchesano, LMCH (617-726-4587, AMARCHESANO@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.