Coach2Move: Sustainable in Daily Practice

Radboud University Medical Center

Status: Completed

Conditions: Physical Activity; Sedentary Lifestyle; Frail Elderly Syndrome

Treatments: Behavioral: Coach2Move; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03212859

104612

Details and patient eligibility

About

Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults.

Full 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.

Enrollment: 292 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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292 participants in 2 patient groups

Coach2Move Intervention Group

Experimental group

Description:

Coach2Move Intervention Group

Treatment:

Behavioral: Coach2Move

Usual Care

Active Comparator group

Description:

Usual care physiotherapy among older adults

Treatment:

Behavioral: Usual Care