Clinical trial NCT04851405: Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago)
Official title: Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age; Debility
Fall
Keywords: Exercise
Strength Training
Fitbit
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Arthritis Research Centre of Canada
name: Vancouver General Hospital
name: Simon Fraser University
name: Vancouver Coastal Health Research Institute
First posted: 2021-04-20
Enrollment: 360
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria (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

Exclusion Criteria (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

Primary outcomes:
measure: Physiotherapist-level outcome - Brief Action Planning (BAP) Scores
timeFrame: During the 12-month intervention
measure: Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)
timeFrame: During the 12-month intervention
Secondary outcomes:
measure: Older Adult-Level Outcome - Number of Falls
timeFrame: During the 12-month intervention
measure: Older Adult-Level Outcome - Number of Falls
timeFrame: During the 12 months after the intervention (i.e., 13-24 months)
measure: Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
timeFrame: Baseline
measure: Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
timeFrame: 6 months
measure: Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
timeFrame: 12 months
measure: Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
timeFrame: 18 months
measure: Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)
timeFrame: 24 months
measure: Older Adult-Level Outcome - Average Daily Step Count
timeFrame: Baseline
measure: Older Adult-Level Outcome - Average Daily Step Count
timeFrame: 6 months
measure: Older Adult-Level Outcome - Average Daily Step Count
timeFrame: 12 months
measure: Older Adult-Level Outcome - Average Daily Step Count
timeFrame: 18 months
measure: Older Adult-Level Outcome - Average Daily Step Count
timeFrame: 24 months
measure: Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
timeFrame: Baseline
measure: Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
timeFrame: 6 months
measure: Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
timeFrame: 12 months
measure: Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
timeFrame: 18 months
measure: Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)
timeFrame: 24 months
measure: Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
timeFrame: Baseline
measure: Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
timeFrame: 3 months
measure: Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
timeFrame: 6 months
measure: Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
timeFrame: 9 months
measure: Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Arthritis Research Canada
state: British Columbia
Study officials:
affiliation: Professor
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: