跳至主要内容
临床试验/NCT04851405
NCT04851405进行中(未招募)不适用

Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults

University of British Columbia1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
35
试验地点
1
主要终点
Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)

研究概览

简要总结

Falls are a major health care problem for seniors. The Otago Exercise Program, which consists of strength and balance training delivered by a physiotherapist, can reduce falls in this population. We will test two methods to deliver the Otago program. These will include a new coaching approach by a physiotherapist with the use of a Fitbit to provide feedback versus the traditional delivery. The degree to which the program is delivered as intended by physiotherapists as well as the number of falls, risk of falling, and participation in walking activities in older adults will be assessed over 24 months. Lastly, we will assess if the coaching approach is a cost-effective option.

详细描述

Falls are a major health care problem for older adults (i.e., those aged ≥ 65 years) and health care systems. Falls account for 50% of injury-related admissions to hospital, 40% of admissions to nursing homes, and a 10% increase in home care services. They are also the leading cause of fatal injury among Canadians over 65 years old. This represents a significant health burden. Fortunately, falls are preventable. There is strong evidence that the Otago Exercise Program (OEP), physiotherapist (PT)-led home-based exercise program of strength and balance training, is effective at preventing falls in older adults with complex medical conditions. Originally developed in New Zealand the OEP has been implemented worldwide, but adherence to the program is a challenge. We propose that the suboptimal adherence is partly due to a lack of focus on behaviour change techniques such as self-monitoring and action planning in the delivery of OEP.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The delivery of OEP+ vs OEP, from PTs, and its recipients, the older adults, will be determined at random. The training for the PT's will be provided by the Centre for Collaboration Motivation & Innovation (CCMI), a non-profit organization with a mandate to support the use of behaviour change techniques to improve health care. Prior to data collection, the PTs will attend a 2-hour workshop on the coaching protocol using the OEP app.

The goal of this project is to assess OEP+ as an implementation strategy to improve OEP delivery (by PTs) and adherence (by older adults).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • (Older Adults):
  • over 70 years of age
  • self-report a non-syncopal fall corroborated by an informant, in the previous six months
  • are able to walk three meters with or without an assistive device
  • have a Mini-Mental State Examination score > 24/30
  • have a Physiological Profile Assessment composite score of at least 1.0 standard deviation above age-normative value or have a Timed Up and Go test > 15 seconds, or had one additional non-syncopal fall in the previous 12 months
  • live in an area served by Vancouver Coastal Health
  • understand, speak, and read English proficiently
  • have access to a mobile device
  • are willing to have their OEP sessions audio-recorded
  • able to provide written informed consent

排除标准

  • (Older Adults):
  • people not meeting the criteria above
  • Inclusion Criteria (Physiotherapists):
  • willing to participate in training on the OEP
  • complete the BAP training
  • be audio-recorded during the OEP sessions
  • be randomized to the OEP group with coaching or without coaching
  • Exclusion Criteria (Physiotherapists):
  • not willing to participate in the above criteria

研究组 & 干预措施

Otago Exercise Programme+ Intervention Group (OEP+)

Active Comparator

Physiotherapists receive OEP training, a 2 hour workshop on the coaching protocol using the OEP app, and online training on the Brief Action Plan Approach with 2 telephone practice sessions with an experienced Brief Action Plan counsellor.

Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up OEP app and Fitbit. PT will return bi-weekly over the course of two months (four visits total) for follow-up. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit. Between Months 7-12, PTs will continue to a phone call follow-up once a month to review the exercise routine.

Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also have access to the OEP app which allows the PT to prescribe exercises and record the participant's exercise goal.

干预措施: Otago Exercise Programme+ (OEP+) (Behavioral)

Otago Exercise Programme Group (OEP)

Placebo Comparator

Physiotherapists receive OEP Training and a 2 hour workshop on just the counselling protocol.

Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up the Fitbit. For the first two months, PTs will provide bi-weekly home visits. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit.

Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also receive a Fitbit. Between Months 7-12, older adults will receive follow-up phone calls from the research staff.

干预措施: Otago Exercise Programme (OEP) (Behavioral)

结局指标

主要结局

Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)

时间窗: During the 12-month intervention

The number of exercise completed out of the total number of exercise prescribed during the intervention period

Physiotherapist-level outcome - Brief Action Planning (BAP) Scores

时间窗: During the 12-month intervention

This measure includes 33 items from three domains: 1) BAP content, 2) warmth and tone, and 3) overall interaction quality (total score: 0-35, higher score = better). The scores will be derived from the physiotherapists' sessions with the first, middle (Participant 3 or 4 out of 8) and last older adult participant. The recording from these treatment sessions will be coded and analysed by one of four researchers. The average of BAP scores of the middle and last participants for each PT will be used in the analysis .

次要结局

  • Older Adult-Level Outcome - Average Daily Step Count(24 months)
  • Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)(12 months)
  • Older Adult-Level Outcome - Number of Falls(During the 12 months after the intervention (i.e., 13-24 months))
  • Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)(24 months)
  • Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)(24 months)
  • Older Adult-Level Outcome - Number of Falls(During the 12-month intervention)
  • Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)(Baseline)
  • Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)(6 months)
  • Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)(12 months)
  • Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)(18 months)
  • Older Adult-Level Outcome - Average Daily Step Count(Baseline)
  • Older Adult-Level Outcome - Average Daily Step Count(6 months)
  • Older Adult-Level Outcome - Average Daily Step Count(12 months)
  • Older Adult-Level Outcome - Average Daily Step Count(18 months)
  • Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)(Baseline)
  • Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)(6 months)
  • Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)(12 months)
  • Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)(18 months)
  • Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)(Baseline)
  • Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)(3 months)
  • Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)(6 months)
  • Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)(9 months)

研究者

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

Linda Li

Principal Investigator

University of British Columbia

研究点 (1)

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