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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Frailty, Aging, Frailty Syndrome, Frail Elderly Syndrome

Intervention / Treatment
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* Behavioral: AGE SELF CARE group visit program


Participation Criteria
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Eligibility Criteria
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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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-group feasibility/acceptability, stage I (NIH stage model for behavioral intervention development)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGE SELF CARE group visit program<br>Participants will take part in 8 weekly 90-minute virtual group visit program sessions | Behavioral: AGE SELF CARE group visit program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, mind-body, pre-frail, healthy aging