Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty
Primary Purpose
Aging
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cafe Move
Sponsored by
About this trial
This is an interventional prevention trial for Aging focused on measuring Frailty, Physical function, Strength, Mobility, Balance
Eligibility Criteria
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
Sites / Locations
- University of Montana
Outcomes
Primary Outcome Measures
Health Behavior Stages of Change Questionnaire
Self-reported measure of engagement with preventive care or wellness activities
Secondary Outcome Measures
Healthcare Access and Utilization Questionnaire
Self-reported measure of healthcare utilization of a number of different services
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05720507
Brief Title
Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty
Official Title
Cafe Move: A Novel Program for Prevention of Age-Related Physical Frailty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Montana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
Frailty, Physical function, Strength, Mobility, Balance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single cohort double baseline design
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cafe Move
Intervention Description
Participants will be offered the opportunity to choose from a number of physical function assessments and subsequently provided personalized reports of performance results.
Primary Outcome Measure Information:
Title
Health Behavior Stages of Change Questionnaire
Description
Self-reported measure of engagement with preventive care or wellness activities
Time Frame
through study completion, average of 4-6 months
Secondary Outcome Measure Information:
Title
Healthcare Access and Utilization Questionnaire
Description
Self-reported measure of healthcare utilization of a number of different services
Time Frame
through study completion, average of 4-6 months
Other Pre-specified Outcome Measures:
Title
Two-minute walk test (2MWT)
Description
Measure of distance walked in 2 minutes along a 50-foot course
Time Frame
through study completion, average of 4-6 months
Title
Grip Strength
Description
Measure of participants' maximum grip strength using a handheld dynamometer
Time Frame
through study completion, average of 4-6 months
Title
Postural Sway
Description
Timed test of participants' ability to balance under 4 different conditions
Time Frame
through study completion, average of 4-6 months
Title
Activities-Specific Balance Confidence Scale
Description
Self-reported questionnaire that assess participants' perceived balance
Time Frame
through study completion, average of 4-6 months
Title
Lifespace Mobility Questionnaire
Description
Self-reported questionnaire that assess participants' interaction with home and community settings
Time Frame
through study completion, average of 4-6 months
Title
Role Participation Questionnaire
Description
Self-reported questionnaire that captures various social, demographic, and activity level information from participants
Time Frame
through study completion, average of 4-6 months
Title
Physical Function Questionnaire
Description
Self-reported questionnaire assessing perceived function with daily activities
Time Frame
through study completion, average of 4-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew J Kittelson, PhD
Phone
406-243-4015
Email
andy.kittelson@umontana.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brian J Loyd
Phone
406-243-4015
Facility Information:
Facility Name
University of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew J Kittelson
Phone
406-243-4015
Email
andy.kittelson@umontana.edu
First Name & Middle Initial & Last Name & Degree
Brian J Loyd
Phone
406-243-4015
Email
brian.loyd@umontana.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty
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