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临床试验/NCT06079762
NCT06079762已完成不适用

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Attendance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Attendance

时间窗: Immediately after the intervention

Proportion of participants who attend at least 6 of 8 scheduled Zoom visits

Completion of home practice log

时间窗: Immediately after the intervention

Proportion of of participants who complete the home practice log each week

Proportion lost to follow-up

时间窗: Immediately after the intervention

Proportion of enrolled participants who were lost to follow-up (unable to be contacted during study)

Recruitment rate

时间窗: Baseline

Proportion of contacted potential participants who enrolled in the study

Participant satisfaction

时间窗: Immediately after the intervention

Participant satisfaction with program, visual analog scale from 1 to 10 (10 indicating highest satisfaction)

Completion of testing

时间窗: Baseline and immediately after the intervention

Proportion of enrolled participants who completed testing for the study; time taken to complete testing

次要结局

  • Loneliness(Baseline and immediately after the intervention)
  • Self-reported health(Baseline and immediately after the intervention)
  • Generalized Anxiety Disorder 2-item scale (GAD-2)(Baseline and immediately after the intervention)
  • Frailty index(Baseline and immediately after the intervention)
  • Sleep(Baseline and immediately after the intervention)
  • Godin Leisure-Time Exercise Questionnaire(Baseline and immediately after the intervention)
  • Self-efficacy(Baseline and immediately after the intervention)
  • Patient health questionnaire 2-item scale (PHQ-2)(Baseline and immediately after the intervention)
  • Short Physical Performance Battery (SPPB)(Baseline and immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Loewenthal

Principal Investigator

Brigham and Women's Hospital

研究点 (2)

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