NCT04779931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

February 26, 2021

Last Update Submit

June 15, 2023

Conditions

Chronic Conditions, Multiple

Outcome Measures

Primary Outcomes (1)

  • User Mobile Application Rating Scale

    Usability; 20 items; Range 0-25, Higher score indicates better usability

    12 weeks

Study Arms (2)

Convoy-Pal Intervention

EXPERIMENTAL

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

Waitlist Control

ACTIVE COMPARATOR

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

Interventions

Convoy-PalBEHAVIORAL

12 week mobile self-management intervention with palliative care resources.

Convoy-Pal InterventionWaitlist Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • DeGroot L, Gillette R, Villalobos JP, Harger G, Doyle DT, Bull S, Bekelman DB, Boxer R, Kutner JS, Portz JD. Feasibility of a digital palliative care intervention (Convoy-Pal) for older adults with heart failure and multiple chronic conditions and their caregivers: a waitlist randomized control trial. BMC Palliat Care. 2024 Oct 1;23(1):234. doi: 10.1186/s12904-024-01561-w.

    PMID: 39354453DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer D Portz, PhD, MSW

    University of Colorado Denver | Anschutz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 3, 2021

Study Start

April 1, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)