Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06079762
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.
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Notify Me65 year–110 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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."
Time frame: Baseline
Proportion of contacted potential participants who enrolled in the study
Time frame: Baseline and immediately after the intervention
Proportion of enrolled participants who completed testing for the study; time taken to complete testing
Time frame: Immediately after the intervention
Proportion of participants who attend at least 6 of 8 scheduled Zoom visits
Time frame: Immediately after the intervention
Proportion of of participants who complete the home practice log each week
Time frame: Immediately after the intervention
Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)
Time frame: Immediately after the intervention
Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)
Time frame: Baseline and immediately after the intervention
Measurement of a frailty index based on the deficit accumulation model (PMID: 32072368)
Time frame: Baseline and immediately after the intervention
University of California at Los Angeles 3-item Loneliness Questionnaire
Time frame: Baseline and immediately after the intervention
General health perception (from SF-12)
Time frame: Baseline and immediately after the intervention
Physical activity
Time frame: Baseline and immediately after the intervention
1 question from New General Self-Efficacy Scale
Time frame: Baseline and immediately after the intervention
Depression
Time frame: Baseline and immediately after the intervention
Anxiety
Time frame: Baseline and immediately after the intervention
Sleep questions from Patient Reported Outcome Measurement Information System (PROMIS-29) questionnaire
Time frame: Baseline and immediately after the intervention
Measures of balance, gait speed, and chair stands
Brigham and Women's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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