Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty

Aging Clinical Trial

Official title:

Cafe Move: A Novel Program for Prevention of Age-Related Physical Frailty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720507
• Other study ID #: 76-22
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: December 2023
• Source: University of Montana
• Contact: Andrew J Kittelson, PhD
• Phone: 406-243-4015
• Email: andy.kittelson[@]umontana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project explores a novel means of health promotion and prevention of age-related physical frailty, which is designed to overcome barriers to access and promote autonomy in managing physical health.

Description:

The purpose of this investigation is to field-test a physical function assessment paradigm, designed to inform people of their physical function relative to peers of similar demographic characteristics (e.g., similar age, sex, height, etc.), to promote recommended preventive health behaviors. The physical function assessment paradigm is known as Cafe Move. Our primary research hypothesis is that people will advance along the stages of behavior change (i.e., more likely to participate in recommended preventive healthcare for physical function), after accessing Cafe Move assessments. This study is a single cohort (n=36 participants), double-baseline design, intended primarily to collect pilot data. The results will inform the design of a larger controlled trial.

This study will examine the safety, feasibility, acceptability, and preliminary efficacy of Café Move. Briefly, we will make Café Move available to at-risk populations (i.e., independent-living older adults) via the following approach. First, during a 3-month control phase, we will monitor participants' health behaviors and engagement with preventive health offerings via periodic phone surveys. We will then make Café Move available and subsequently monitor health behaviors and engagement with preventive health offerings. This design will allow us to examine feasibility of the Café Move intervention, to better understand the reach of the program within and across communities, and to determine variance and covariance for the outcome measures of interest.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 28, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Legally autonomous to consent

• Lives independently

• Ability to sit, stand, and walk without the assistance of another person

Exclusion Criteria:

• Not legally autonomous to consent

• Institutionalized

Related Conditions & MeSH terms

• Aging
• Frailty

Intervention

Behavioral:
• Cafe Move
Participants will be offered the opportunity to choose from a number of physical function assessments and subsequently provided personalized reports of performance results.

Locations

Country	Name	City	State
United States	University of Montana	Missoula	Montana

Sponsors (1)

Lead Sponsor	Collaborator
University of Montana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Two-minute walk test (2MWT)	Measure of distance walked in 2 minutes along a 50-foot course	through study completion, average of 4-6 months
Other	Grip Strength	Measure of participants' maximum grip strength using a handheld dynamometer	through study completion, average of 4-6 months
Other	Postural Sway	Timed test of participants' ability to balance under 4 different conditions	through study completion, average of 4-6 months
Other	Activities-Specific Balance Confidence Scale	Self-reported questionnaire that assess participants' perceived balance	through study completion, average of 4-6 months
Other	Lifespace Mobility Questionnaire	Self-reported questionnaire that assess participants' interaction with home and community settings	through study completion, average of 4-6 months
Other	Role Participation Questionnaire	Self-reported questionnaire that captures various social, demographic, and activity level information from participants	through study completion, average of 4-6 months
Other	Physical Function Questionnaire	Self-reported questionnaire assessing perceived function with daily activities	through study completion, average of 4-6 months
Primary	Health Behavior Stages of Change Questionnaire	Self-reported measure of engagement with preventive care or wellness activities	through study completion, average of 4-6 months
Secondary	Healthcare Access and Utilization Questionnaire	Self-reported measure of healthcare utilization of a number of different services	through study completion, average of 4-6 months