- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779931
Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults (ConvoyPal)
June 15, 2023 updated by: University of Colorado, Denver
The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
12 week mobile self-management intervention with palliative care resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
User Mobile Application Rating Scale
Time Frame: 12 weeks
|
Usability; 20 items; Range 0-25, Higher score indicates better usability
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer D Portz, PhD, MSW, University of Colorado Denver | Anschutz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0973
- K76AG059934 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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