Clinical Trials Directory

Trials / Completed

CompletedNCT03212859

Coach2Move: Sustainable in Daily Practice

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
292 (actual)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCoach2MoveCoach2Move is a multicomponent physiotherapeutic approach in addition to usual care physiotherapy consisting of: * Extensive intake during which not only impairments and disabilities, but wishes, barriers and facilitators considering physical functioning are profoundly examined. * Motivational interviewing is used to find and deal with barriers for becoming physically active and shared-decision making in goal setting. * The approach is patient focused (tailor made) and goal-oriented: the physiotherapist coaches the patient and the environment in reaching and maintaining their own goals. * In consultation with the patient, a stratified intervention is chosen by picking the best fitting option out of three patient-tailored intervention profiles with a predefined number of intervention sessions.
BEHAVIORALUsual CareUsual care physiotherapy among older adults: * Intake of 30 minutes consisting of examining medical history, physical functioning and functional exercises to assess the demand for care. * Use of treatment modalities to enhance physical functioning (strength, mobility, coordination, balance etc.) * Consultation and advisory role in relation to the functional status of geriatric patients and his/her relations. * Collaborate with other disciplines in a multidisciplinary context.

Timeline

Start date
2017-11-06
Primary completion
2020-09-04
Completion
2020-09-04
First posted
2017-07-11
Last updated
2021-03-17

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03212859. Inclusion in this directory is not an endorsement.