Clinical trial NCT06079762: AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program
Official title: AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Aging
Frailty Syndrome
Frail Elderly Syndrome
Keywords: yoga
mind-body
pre-frail
healthy aging
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-group feasibility/acceptability, stage I (NIH stage model for behavioral intervention development)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Completion of testing
timeFrame: Baseline and immediately after the intervention
measure: Attendance
timeFrame: Immediately after the intervention
measure: Completion of home practice log
timeFrame: Immediately after the intervention
measure: Participant satisfaction
timeFrame: Immediately after the intervention
measure: Proportion lost to follow-up
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Frailty index
timeFrame: Baseline and immediately after the intervention
measure: Loneliness
timeFrame: Baseline and immediately after the intervention
measure: Self-reported health
timeFrame: Baseline and immediately after the intervention
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: Baseline and immediately after the intervention
measure: Self-efficacy
timeFrame: Baseline and immediately after the intervention
measure: Patient health questionnaire 2-item scale (PHQ-2)
timeFrame: Baseline and immediately after the intervention
measure: Generalized Anxiety Disorder 2-item scale (GAD-2)
timeFrame: Baseline and immediately after the intervention
measure: Sleep
timeFrame: Baseline and immediately after the intervention
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Julia Loewenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: