Coach2Move: Sustainable in Daily Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 292
- Locations
- 2
- Primary Endpoint
- Self-reported Physical Activity
Study Overview
Brief Summary
Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults.
Detailed Description
In a previous trial, researchers demonstrated that the Coach2Move approach is superior to regular physiotherapy in terms of increasing physical activity, reducing frailty, improving quality of life and reducing healthcare costs. In short, in less physiotherapeutic sessions, better outcomes were realized.
Despite these promising findings, the research group still has questions regarding the generalisability of these findings. The reservations towards the generalisability of the approach are caused by the following:
- A modest (n=130), yet somewhat selective study sample was included: nearly half of the eligible individuals declined randomisation and thereby participation. An understanding is needed how this group of eligible non volunteers respond to Coach2Move. Therefore, a study design that avoids randomisation at the patient level will be used.
- The Coach2Move approach significantly increased the level of moderate physical activity among the treatment group and reduced levels of frailty significantly after 6 months, but the clinical importance of these findings is still unclear. Thus, a replication of the effects in the light of physical functioning is needed in a larger more variable study population and with a longer follow-up.
In addition, the results from the earlier carried out RCT concerning the cost-effectiveness of Coach2Move have to be replicated on a larger scale.
For the reasons mentioned above, it is important to further implement Coach2Move and study its effect, costs, and feasibility in current practice. A stepped wedge cluster randomised trial design is chosen because in the opinion of the researchers, the implementation strategy will do more good than harm (making a parallel design, in which certain practices do not receive the intervention or to withdraw the intervention as would occur in a cross-over design, is unethical) and it furthermore minimizes contamination.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 70 years or older
- •Community-dwelling
- •mobility related problems or problems related to activities of daily living
- •sedentary lifestyle or are at risk of losing an active lifestyle
Exclusion Criteria
- •Patients who are not ambulatory after treatment and/or are in palliative phase.
- •Patients who are indicated to become institutionalised in the near future.
Outcomes
Primary Outcomes
Self-reported Physical Activity
Time Frame: 27 months
The primary outcome of the study is physical activity measured by the LAPAQ questionnaire, subscale moderate activity. This subscale of the LAPAQ is a comprehensive questionnaire on diverse (physical) activities of daily living with moderate intensity including walking, riding a bicycle etc. and is specifically designed to assess habitual physical activity of the elderly.
Functional Mobility
Time Frame: 27 months
The key secondary outcome is functional mobility as measured by the Timed Up and Go test.
Secondary Outcomes
- Functional Status(12 months)
- Cost effectiveness(27 months)
- Patient Satisfaction(27 months)
- Level of Frailty(27 months)
