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Trial record 1 of 1 for:    NCT03861429
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Me & My Wishes: An Efficacy Trial Using Videos

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ClinicalTrials.gov Identifier: NCT03861429
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Brown University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Gail Towsley, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Health Communication Behavioral: Me & My Wishes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Me & My Wishes: An Efficacy Trial of Long Term Care Residents With Alzheimer's Using Videos to Communicate Care Preferences With Caregivers
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Me & My Wishes Intervention/Group 1
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Behavioral: Me & My Wishes
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.

Me & My Wishes Wait-list control/Group 2
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.
Behavioral: Me & My Wishes
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.




Primary Outcome Measures :
  1. Communication of preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Goals of care discussions (change in documentation in medical record, e.g. social work note)

  2. Communication of preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Self-reported conversations (change in self report: resident, family, staff surveys)


Secondary Outcome Measures :
  1. Confidence of communicating preferences [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Confidence in expressing or communicating about resident preferences; 1) change in resident, Family, Staff Survey (self-efficacy items, range 1-5, higher is more confident); 2) New or changed care planning documents (e.g. POLST)


Other Outcome Measures:
  1. Congruence of preferences observed in video [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in video

  2. Congruence of preferences observed in medical record [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in medical record via medical record review

  3. Congruence of preferences observed in video, medical record, and surveys [ Time Frame: Baseline, time of sharing (within 72 hours of sharing video), and 90 days post sharing video ]
    Presence/absence of preferences in video 1) Describe presence/absence of preferences in surveys via self-report surveys



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861429


Contacts
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Contact: Gail L Towsley, PhD 801-585-9085 gail.towsley@nurs.utah.edu

Locations
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United States, Oregon
Marquis Hope Village Assisted Living Recruiting
Canby, Oregon, United States, 97209
Contact: Gail Towsley    801-585-9085    gail.towsley@nurs.utah.edu   
Marquis Forest Grove Assisted Living Completed
Forest Grove, Oregon, United States, 97116
Marquis Forest Grove Post Acute Rehab Recruiting
Forest Grove, Oregon, United States, 97116
Contact: Gail Towsley    801-585-9085    gail.towsley@nurs.utah.edu   
Regency Gresham Nursing and Rehabilitation Center Recruiting
Gresham, Oregon, United States, 97080
Contact: Gail Towsley    801-585-9085    gail.towsley@nurs.utah.edu   
Marquis Oregon City Post Acute Rehab Withdrawn
Oregon City, Oregon, United States, 97045
Marquis Wilsonville Assisted Living Recruiting
Wilsonville, Oregon, United States, 97070
Contact: Gail Towsley    801-585-9085    gail.towsley@nurs.utah.edu   
Marquis Wilsonville Post Acute Rehab Recruiting
Wilsonville, Oregon, United States, 97070
Contact: Gail Towsley    801-585-9085    gail.towsley@nurs.utah.edu   
French Prairie Nursing and Rehab Completed
Woodburn, Oregon, United States, 97071
United States, Washington
Woodland Care Center Completed
Woodland, Washington, United States, 98674
Sponsors and Collaborators
University of Utah
Brown University
National Institute on Aging (NIA)
  Study Documents (Full-Text)

Documents provided by Gail Towsley, University of Utah:
Informed Consent Form  [PDF] July 17, 2019

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Responsible Party: Gail Towsley, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03861429    
Other Study ID Numbers: IRB_00111417
1R21AG058094 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No