Coach2Move: Sustainable in Daily Practice

Not Applicable

Completed

• Conditions: Physical Activity; Frail Elderly Syndrome; Sedentary Lifestyle
• Interventions: Behavioral: Coach2Move; Behavioral: Usual Care

• Registration Number: NCT03212859
• Lead Sponsor: Radboud University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-11-06
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coach2Move Intervention Group	Coach2Move	Coach2Move Intervention Group
Usual Care	Usual Care	Usual care physiotherapy among older adults

Primary Outcome Measures

Name	Time	Method
Self-reported Physical Activity	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	27 months	The key secondary outcome is functional mobility as measured by the Timed Up and Go test.

Secondary Outcome Measures

Name	Time	Method
Functional Status	12 months	The Patient Specific Complaints Scale is used to measure the functional status of a patient. The patients select 3-5 most important mobility problems in daily life and are the most important goals to improve. The degree of hinder is scored by the patient on a 10-point numeric scale.
Cost effectiveness	27 months	The direct costs of regular physiotherapy and Coach2Move will be determined on a per patient basis. On patient level, volumes of care will be measured prospectively using medical records and cost questionnaires.; Next will be determining the cost prices for each volume of consumption in order to use these for the volumes registered for each participating patient.; Both outcome measures will be aggregated to one reported value (cost per volume x volumes used). A comparison in costs will be made between the Coach2Move and usual care groups.
Patient Satisfaction	27 months	The Global Perceived Satisfaction and Effect score is used to measure the patients' satisfaction about the intervention and the perceived effect on a 7-point Likert scale ranging from very unsatisfied to very much satisfied and very much deterioration to very much improvement, respectively.
Level of Frailty	27 months	To measure the level of frailty and participation, the Evaluative Frailty Index is used. This questionnaire consists of 50 items on deficits in health (symptoms, signs and disabilities) in multiple domains (physical, psychological, social and general health status).

Trial Locations

Locations (1)

Ward Heij; 🇳🇱 Nijmegen, Gelderland, Netherlands