Clinical trial NCT03212859: Coach2Move: Sustainable in Daily Practice
Official title: Coach2Move: Sustainable in Daily Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Frail Elderly Syndrome
Keywords: older adults
physiotherapy
physical activity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2017-07-11
Enrollment: 292
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped wedge cluster randomised trial and mixed methods process analysis
Primary purpose: TREATMENT

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:

1. 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.
2. 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.

The objective of this study is to assess the cost-effectiveness of the implementation of a patient and context focused tailored coaching intervention (Coach2Move) in the daily physiotherapy practice for older adults with mobility problems compared to usual physiotherapy. The hypothesis is that Coach2Move leads to better physical outcomes and lower costs than usual care.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported Physical Activity
timeFrame: 27 months
measure: Functional Mobility
timeFrame: 27 months
Secondary outcomes:
measure: Functional Status
timeFrame: 12 months
measure: Cost effectiveness
timeFrame: 27 months
measure: Patient Satisfaction
timeFrame: 27 months
measure: Level of Frailty
timeFrame: 27 months
Other outcomes:
measure: Implementability
timeFrame: 27 months
measure: Budget Impact
timeFrame: 27 months
Locations:
city: Nijmegen
country: Netherlands
facility: Ward Heij
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Ward Heij, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heij W, Teerenstra S, Sweerts L, Staal JB, Nijhuis-van der Sanden MWG, Hoogeboom TJ. Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial. Phys Ther. 2020 Apr 17;100(4):653-661. doi: 10.1093/ptj/pzz183.