AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program

NCT06079762 | Completed

• 1 other identifier: 2023P001407
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: To assess the feasibility and acceptability of delivering AGE SELF CARE through virtual medical group visits by measuring recruitment rate, adherence, and participant satisfaction. Hypothesis 1: It will be feasible to recruit 12 older adults who are pre-frail. Hypothesis 2: At least 70% of participants will attend 6 of 8 group visit sessions. Hypothesis 3: At least 70% of participants will report satisfaction with the program. Aim 2: Determine the feasibility and burden of measuring frailty in this study by different instruments. Hypothesis 1: At least 70% of participants will complete portions of all frailty assessments. Hypothesis 2: Participants will not find testing to be burdensome and measures may be completed in 60 minutes or less. Hypothesis 3: Mean gait speed and frailty index will improve from baseline to post-intervention.

Conditions

Frailty; Aging; Frailty Syndrome; Frail Elderly Syndrome

Keywords

yoga; mind-body; pre-frail; healthy aging

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Proportion of contacted potential participants who enrolled in the study

  Baseline

• Completion of testing

  Proportion of enrolled participants who completed testing for the study; time taken to complete testing

  Baseline and immediately after the intervention

• Attendance

  Proportion of participants who attend at least 6 of 8 scheduled Zoom visits

  Immediately after the intervention

• Completion of home practice log

  Proportion of of participants who complete the home practice log each week

  Immediately after the intervention

• Participant satisfaction

  Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)

  Immediately after the intervention

• Proportion lost to follow-up

  Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

  Immediately after the intervention

Secondary Outcomes (9)

• Frailty index

  Baseline and immediately after the intervention

• Loneliness

  Baseline and immediately after the intervention

• Self-reported health

  Baseline and immediately after the intervention

• Godin Leisure-Time Exercise Questionnaire

  Baseline and immediately after the intervention

• Self-efficacy

  Baseline and immediately after the intervention

Study Arms (1)

AGE SELF CARE group visit program

EXPERIMENTAL

Participants will take part in 8 weekly 90-minute virtual group visit program sessions

Behavioral: AGE SELF CARE group visit program

Interventions

AGE SELF CARE group visit program BEHAVIORAL

AGE SELF CARE: "Adaptation, Growth, and Engagement; Socialization, Empowerment, Learning, and Function; and Community Activation for Resilience in Elderhood," is a virtual group visit program. It includes education and behavioral change elements in the broad areas of self/health, home environment, and community. There are 8 weekly 90-minute virtual sessions facilitated by an aging expert (e.g., geriatrician). Examples of topics include "Aging Well: The Power of Movement," "People Can Change, Homes Can Too," and "Social World."

AGE SELF CARE group visit program

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling adults age 65+.
• Pre-frail (1-2 points on FRAIL scale) during pre-screening.
• Agree to participate and commit to all study procedures.
• Able to speak English.
• Access to and ability to use a smartphone, tablet, or computer and broadband internet.

You may not qualify if:

• Younger than age 65.
• Robust (0 points) or frail (3+ points) on FRAIL scale during phone screening.
• Established diagnosis of dementia.
• Untreated psychiatric symptoms affecting group participation.
• Hearing or visual impairment affecting participation in a virtual program.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Loewenthal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-group feasibility/acceptability, stage I (NIH stage model for behavioral intervention development)

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2023
• Primary Completion: March 29, 2024
• Study Completion: August 5, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)