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Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults (ConvoyPal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779931
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
The aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Feasibility will be assessed by recruitment, attrition, and data collection on measures of quality of life and social support. Usability will be captured by self-report usability scales and actual back end utilization data.

Condition or disease Intervention/treatment Phase
Chronic Conditions, Multiple Behavioral: Convoy-Pal Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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Arm Intervention/treatment
Experimental: Convoy-Pal Intervention
Intervention participants will be sent Convoy-Pal equipment and materials. The equipment can simply be removed from the box, plugged in, and turned on to start. Research staff will provide technical support as needed during the trial. Convoy-Pal is 12-week intervention that uses the Routinify platform to deliver self-management tools and palliative care resources in the participants' home. The platform includes a tablet, charging stand, and smart watch, with additional options for mobile phone access and a website portal.
 Behavioral: Convoy-Pal
12 week mobile self-management intervention with palliative care resources.
Active Comparator: Waitlist Control
Participants will complete baseline assessments and will be recontacted at 11 weeks to complete follow up assessments at week 12. Participants will receive a $25 gift card for each assessment ($50 total). If they would like to try the intervention at that time, we will send them Convoy-Pal equipment and materials. They will then have 12 weeks to use the tool.
 Behavioral: Convoy-Pal
12 week mobile self-management intervention with palliative care resources.


Outcome Measures
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Primary Outcome Measures :
  1. User Mobile Application Rating Scale [ Time Frame: 12 weeks ]
    Usability; 20 items; Range 0-25, Higher score indicates better usability


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥65 years of age
  • self-report diagnosis of heart failure (HF)
  • have multiple chronic conditions (MCC) based on the Disease Burden/Morbidity Assessment by Self-Report (Individuals will be eligible if they self-report the number of diagnosis > 2 and a disease burden score >2 indicating the presence of at least two chronic conditions that limit activities of daily of living)
  • community dwelling in the United States
  • English speaking

Exclusion Criteria:

  • Self-reported diagnosis of Alzheimer's disease or dementia
  • Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
  • Participation in community-based palliative care in the last 12 months
Contacts and Locations
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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): NCT04779931


Contacts
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Contact: Jennifer Portz, PhD, MSW (303) 724-4438 Jennifer.portz@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer D Portz, PhD       Jennifer.portz@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jennifer D Portz, PhD, MSW University of Colorado Denver | Anschutz
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04779931    
Other Study ID Numbers: 18-0973
K76AG059934 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
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
Additional relevant MeSH terms:
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Multiple Chronic Conditions
Chronic Disease
Disease Attributes
Pathologic Processes