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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06079762
Enrollment
11
Registered
2023-10-12
Start date
2023-10-01
Completion date
2024-08-05
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Frail Elderly Syndrome, Frailty, Frailty Syndrome

Keywords

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

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.

Interventions

BEHAVIORALAGE 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.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to 110 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AttendanceImmediately after the interventionProportion of participants who attend at least 6 of 8 scheduled Zoom visits
Recruitment rateBaselineProportion of contacted potential participants who enrolled in the study
Completion of testingBaseline and immediately after the interventionProportion of enrolled participants who completed testing for the study; time taken to complete testing
Completion of home practice logImmediately after the interventionProportion of of participants who complete the home practice log each week
Participant satisfactionImmediately after the interventionParticipant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)
Proportion lost to follow-upImmediately after the interventionProportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder 2-item scale (GAD-2)Baseline and immediately after the interventionAnxiety
Frailty indexBaseline and immediately after the interventionMeasurement of a frailty index based on the deficit accumulation model (PMID: 32072368)
Short Physical Performance Battery (SPPB)Baseline and immediately after the interventionMeasures of balance, gait speed, and chair stands
SleepBaseline and immediately after the interventionSleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire
LonelinessBaseline and immediately after the interventionUniversity of California at Los Angeles 3-item Loneliness Questionnaire
Self-reported healthBaseline and immediately after the interventionGeneral health perception (from SF-12)
Godin Leisure-Time Exercise QuestionnaireBaseline and immediately after the interventionPhysical activity
Self-efficacyBaseline and immediately after the intervention1 question from New General Self-Efficacy Scale
Patient health questionnaire 2-item scale (PHQ-2)Baseline and immediately after the interventionDepression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026