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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079762

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Aging Frailty Syndrome Frail Elderly Syndrome	Behavioral: AGE SELF CARE group visit program	N/A

Detailed Description

Study Design: pilot study

Setting: BWH Osher Clinical Center for Integrative Medicine, or "OCC", is a collaboration between BWH and Harvard Medical School (HMS), focused on enhancing human health, resilience, and quality of life through translational research, clinical practice, and education in integrative medicine. The OCC is comprised of an interdisciplinary team of physicians, chiropractors, acupuncturists, massage therapists, coaches, nutritionists, craniosacral therapists, and other practitioners who treat patients with a variety of conditions. Patients across New England regularly access the OCC through self-referral or referral from primary care or subspecialty practices.

Participants: Community-dwelling adults aged 65 years and older who are pre-frail (based on FRAIL) during the initial study visit (n=12).

Intervention: AGE SELF CARE consists of 8 weekly 90-minute virtual group visits, with approximately 12 participants in each group. Sessions focus on chronic disease management; healthy lifestyle education, including nutrition, physical activity, sleep, stress management, and socialization; home adaptation to optimize the home environment for usability and safety with aging; and anticipatory guidance. Educational materials include a library of handouts and pre-recorded videos from interdisciplinary team members about a topic. The group applies learning to their own lives, develops personal goals, and reports back about brief home activities or practices.

Sessions will be modified and targeted toward frailty prevention according to existing data and published guidelines. For example, the Mediterranean diet will be discussed as a nutritional approach that can reduce frailty progression. Physical activity guidelines will focus on resistance training to simulate daily activities, power training, balance exercise, and mind-body movement. Finally, sessions will include information on home safety modification and polypharmacy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGE SELF CARE group visit program Participants will take part in 8 weekly 90-minute virtual group visit program sessions	Behavioral: AGE SELF CARE group visit program 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."

Arm

Intervention/Treatment

Experimental: AGE SELF CARE group visit program

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

Behavioral: AGE SELF CARE group visit program

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."

Outcome Measures

Primary Outcome Measures

Recruitment rate [Baseline]
Proportion of contacted potential participants who enrolled in the study
Completion of testing [Baseline and immediately after the intervention]
Proportion of enrolled participants who completed testing for the study; time taken to complete testing
Attendance [Immediately after the intervention]
Proportion of participants who attend at least 6 of 8 scheduled Zoom visits
Completion of home practice log [Immediately after the intervention]
Proportion of of participants who complete the home practice log each week
Participant satisfaction [Immediately after the intervention]
Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)
Proportion lost to follow-up [Immediately after the intervention]
Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

Secondary Outcome Measures

Frailty index [Baseline and immediately after the intervention]
Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)
Loneliness [Baseline and immediately after the intervention]
University of California at Los Angeles 3-item Loneliness Questionnaire
Self-reported health [Baseline and immediately after the intervention]
General health perception (from SF-12)
Godin Leisure-Time Exercise Questionnaire [Baseline and immediately after the intervention]
Physical activity
Self-efficacy [Baseline and immediately after the intervention]
1 question from New General Self-Efficacy Scale
Patient health questionnaire 2-item scale (PHQ-2) [Baseline and immediately after the intervention]
Depression
Generalized Anxiety Disorder 2-item scale (GAD-2) [Baseline and immediately after the intervention]
Anxiety
Sleep [Baseline and immediately after the intervention]
Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire
Short Physical Performance Battery (SPPB) [Baseline and immediately after the intervention]
Measures of balance, gait speed, and chair stands

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.