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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04779931
Other study ID # 18-0973
Secondary ID K76AG059934
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date May 30, 2023

Study information

Verified date June 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Convoy-Pal
12 week mobile self-management intervention with palliative care resources.

Locations

Country Name City State
United States University of Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary User Mobile Application Rating Scale Usability; 20 items; Range 0-25, Higher score indicates better usability 12 weeks
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