Health CommunicationNCT03861429
Me & My Wishes: An Efficacy Trial Using Videos
A study testing Me & My Wishes in people with Health Communication, run by University of Utah at 8 sites in United States.
Trial summary
The aim of this study is to determine whether the Me \& My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Health Communication
- What is being tested?
- Me & My Wishes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Apr 2019to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Resident Inclusion Criteria:
- Identified as having Alzheimer's or related dementia
- Mild to moderate cognitive impairment (BIMS = 8-15, (MDS C0500) (nursing home residents only)
- Makes Self Understood = <1 (MDS B0700)/present in medical record
- Understood By Others = <1 (MDS B0800)/present in medical record
- Reside at the facility at least 2 weeks identified as a long-term resident
- Age >65 years
- Speaks English
Family Inclusion Criteria:
- Speaks English
- Willing and able to watch the videos
- Willing to complete short surveys. Being unable to attend care conference to view the video (e.g. due to distance) will not exclude family from participating.
Staff Inclusion Criteria:
- Speaks English
- Willing to watch the videos
- Willing to complete short surveys
Resident Exclusion Criteria:
- Limited communication capacity (e.g. aphasia)
- Comatose
- Cognitively intact
- Severe cognitive impairment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Marquis Hope Village Assisted Living
Canby, Oregon, 97209
Marquis Forest Grove Assisted Living
Forest Grove, Oregon, 97116
Marquis Forest Grove Post Acute Rehab
Forest Grove, Oregon, 97116
Regency Gresham Nursing and Rehabilitation Center
Gresham, Oregon, 97080
Marquis Wilsonville Assisted Living
Wilsonville, Oregon, 97070
Marquis Wilsonville Post Acute Rehab
Wilsonville, Oregon, 97070
French Prairie Nursing and Rehab
Woodburn, Oregon, 97071
Woodland Care Center
Woodland, Washington, 98674
About this study
Official title: Me & My Wishes: An Efficacy Trial of Long Term Care Residents With Alzheimer's Using Videos to Communicate Care Preferences With Caregivers
The aim of this study is to determine whether the Me \& My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.
Read the detailed description
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and EOL preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to conduct a Stage II efficacy trial of Me \& My Wishes-a novel approach for communicating resident care preferences-by creating videos with 48-54 nursing home residents with mild to moderate dementia and sharing their personalized video with informal (family) and formal (staff) caregivers. The investigators will employ a randomized wait-list control design in which residents in control nursing homes will delay sharing their video. Videos may be viewed two ways: 1) in resident quarterly care conferences; and 2) via a web-based link with resident-identified family members or friends.
- Conditions
- Health Communication
- Being tested
- Me & My Wishes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Me & My WishesBehavioural
Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
| Study group | Role | What they receive |
|---|---|---|
| Me & My Wishes Intervention/Group 1 | Experimental | In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. Receives: Behavioral: Me & My Wishes |
| Me & My Wishes Wait-list control/Group 2 | Other | In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. Receives: Behavioral: Me & My Wishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Documented Discussion of Goals of Care
At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point.
Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions.
Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused
Measured: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Secondary outcomes (1)
Self-efficacy for Communicating Preferences
Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident.
Measured: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start9 Apr 2019
- Primary completion29 Jan 2020
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health CommunicationStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Sequential
- Model description
- The investigators propose Stage II efficacy testing of Me \& My Wishes using a randomized wait-list control design that allows the investigators to compare the effects between an early intervention group (Group 1) and a wait-list "control" group (Group 2).Six NHs matched on number of beds and payor mix will be randomly assigned to one of two groups.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Gail Towsley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861429
- Sponsor's protocol ID
- IRB_00111417
- Other IDs
- 1R21AG058094
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2019
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Towsley GL, Neller S, Baier RR, Wong B. Me & My Wishes: Concordance of End-of-Life Preferences between Residents with Dementia, Family, and Staff. J Palliat Med. 2022 Jun;25(6):880-887. doi: 10.1089/jpm.2021.0111. Epub 2021 Dec 28.
PubMed 34962157
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Me & My Wishes: An Efficacy Trial of Long Term Care Residents With Alzheimer's Using Videos to Communicate Care Preferences With Caregivers
- ClinicalTrials.gov ID
- NCT03861429
- Acronym / sponsor ID
- IRB_00111417
- Conditions
- Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether the Me \& My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.
Detailed description
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and EOL preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to conduct a Stage II efficacy trial of Me \& My Wishes-a novel approach for communicating resident care preferences-by creating videos with 48-54 nursing home residents with mild to moderate dementia and sharing their personalized video with informal (family) and formal (staff) caregivers. The investigators will employ a randomized wait-list control design in which residents in control nursing homes will delay sharing their video. Videos may be viewed two ways: 1) in resident quarterly care conferences; and 2) via a web-based link with resident-identified family members or friends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators propose Stage II efficacy testing of Me \& My Wishes using a randomized wait-list control design that allows the investigators to compare the effects between an early intervention group (Group 1) and a wait-list "control" group (Group 2).Six NHs matched on number of beds and payor mix will be randomly assigned to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Me & My Wishes Intervention/Group 1 | Experimental | Behavioral: Me & My WishesIn Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline. |
| Me & My Wishes Wait-list control/Group 2 | Other | Behavioral: Me & My WishesIn Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Me & My WishesMe \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. | Behavioural | Me & My Wishes Intervention/Group 1, Me & My Wishes Wait-list control/Group 2 |
Primary outcome
Number of Participants With a Documented Discussion of Goals of Care
Time frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point. Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions. Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused
1 secondary outcome
Self-efficacy for Communicating Preferences
Time frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34962157Towsley GL, Neller S, Baier RR, Wong B. Me & My Wishes: Concordance of End-of-Life Preferences between Residents with Dementia, Family, and Staff. J Palliat Med. 2022 Jun;25(6):880-887. doi: 10.1089/jpm.2021.0111. Epub 2021 Dec 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Me & My Wishes in people with Health Communication, run by University of Utah at 8 sites 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?
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: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Documented Discussion of Goals of Care (time frame: Baseline, time of sharing (3 months from baseline), and 90 days post sharing video). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861429, which also lists 1 linked publication.
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 26 Jun 2024.