Health CommunicationNCT05037448
Exploring Telehealth to Deliver Me & My Wishes During Coronavirus-19
A study testing Me & My Wishes in people with Health Communication, run by University of Utah at 3 sites in United States.
Trial summary
Due to Coronavirus-19, we are exploring the plausibility of delivering the Me \& My Wishes intervention via telehealth. 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
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2020to 28 Feb 2021
- 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 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
3 sites in 1 country.
United States3 sites
Mission at Maple Springs
Brigham City, Utah, 84032
Marquis Forest Grove Post Acute Rehab
Forest Grove, Oregon, 97116
Marquis Wilsonville Assisted Living
Wilsonville, Oregon, 97070
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
Due to Coronavirus-19, we are exploring the plausibility of delivering the Me \& My Wishes intervention via telehealth.
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 end of life 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 explore the feasibility of delivering Me \& My Wishes via a telehealth platform.
- 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 |
|---|---|---|
| Telehealth | Other | 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. Receives: Behavioral: Me & My Wishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of telehealth-delivered Me & My Wishes
ease of use, connecting to internet, communicating with participants. 1-5 scale 1 = strongly disagree, 5 = strongly agree; we also asked what worked well and what could go better
Measured: baseline
Feasibility of telehealth-delivered Me & My Wishes
ease of use, connecting to internet, communicating with participants. 1-5 scale 1 = strongly disagree, 5 = strongly agree; we also asked what worked well and what could go better
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start17 Aug 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators propose to examine the plausibility of delivering Me \& My Wishes using a telehealth platform. A convenience sample of five residents, their family members and long term care staff will be enrolled.
- Masking
- None (open label)
- Enrolment
- 17 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
- Investigators
- Gail Towsley, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037448
- Sponsor's protocol ID
- I00111417
- Status last verified
- Mar 2021
- First submitted
- 24 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. 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
- NCT05037448
- Acronym / sponsor ID
- I00111417
- Conditions
- Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 8 Sep 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.
Due to Coronavirus-19, we are exploring the plausibility of delivering the Me \& My Wishes intervention via telehealth.
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 end of life 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 explore the feasibility of delivering Me \& My Wishes via a telehealth platform.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators propose to examine the plausibility of delivering Me \& My Wishes using a telehealth platform. A convenience sample of five residents, their family members and long term care staff will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Other | Behavioral: 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. |
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 | Telehealth |
Primary outcome
Feasibility of telehealth-delivered Me & My Wishes
Time frame: baseline
ease of use, connecting to internet, communicating with participants. 1-5 scale 1 = strongly disagree, 5 = strongly agree; we also asked what worked well and what could go better
Feasibility of telehealth-delivered Me & My Wishes
Time frame: 90 days
ease of use, connecting to internet, communicating with participants. 1-5 scale 1 = strongly disagree, 5 = strongly agree; we also asked what worked well and what could go better
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- 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.
Gail Towsley principal investigator
University of Utah
3 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 3 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of telehealth-delivered Me & My Wishes (time frame: baseline). The study lists 2 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 8 Sep 2021.