search
Back to results

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

Primary Purpose

Chronic Conditions, Multiple

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Convoy-Pal
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Conditions, Multiple

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Convoy-Pal Intervention

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

User Mobile Application Rating Scale
Usability; 20 items; Range 0-25, Higher score indicates better usability

Secondary Outcome Measures

Full Information

First Posted
February 26, 2021
Last Updated
June 15, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04779931
Brief Title
Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
Acronym
ConvoyPal
Official Title
The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Conditions, Multiple

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convoy-Pal Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Convoy-Pal
Intervention Description
12 week mobile self-management intervention with palliative care resources.
Primary Outcome Measure Information:
Title
User Mobile Application Rating Scale
Description
Usability; 20 items; Range 0-25, Higher score indicates better usability
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D Portz, PhD, MSW
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs