Reducing sample size by combining superiority and non-inferiority for two primary endpoints in the Social Fitness study

Donkers, H.W.; Graff, Maud; Vernooij‐Dassen, Myrra; Sanden, Maria W. G. Nijhuis-van der; Teerenstra, Steven

doi:10.1016/j.jclinepi.2016.09.007

Cited by 3 publications

(2 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Effectiveness on health outcomes has been defined when at least 1 of the primary outcomes improves while the other does not deteriorate. 16 The expected power of the combined objective for 360 patients was 86%.…”

Section: Methodsmentioning

confidence: 98%

“…Because of the hierarchical design (patients nested within clusters, practices, and therapists), multilevel linear analysis was used to compare estimated means between UCP and Coach2Move participants with (nested) random effects for cluster, practice, and therapist. 16 Given variances \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}${\sigma}_1^2,{\sigma}_2^2,{\sigma}_3^2$\end{document} at level 1 (older adults), at level 2 (physical therapist) and level 3 (practice), intracluster correlations were calculated as \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$\mathrm{IC}{\mathrm{C}}_{12}=\Big({\sigma}_2^2+{\sigma}_3^2\Big)/\Big({\sigma}_1^2+{\sigma}_2^2+{\sigma}_3^2\Big)$\end{document} and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$\mathrm{IC}{\mathrm{C}}_{23}={\sigma}_3^2/\Big({\sigma}_2^2+{\sigma}_3^2\Big)$\end{document} . These are the correlation of older adults within their physical therapist and the correlation of physical therapists within their practice.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial

Heij¹,

Sweerts²,

Staal

et al. 2022

Physical Therapy

Self Cite

View full text Add to dashboard Cite

Objective The purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)—which was demonstrated in a previous trial when compared to usual care physical therapy (UCP)—can be replicated in daily clinical practice. Methods A multicenter cluster-randomized stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed “Up & Go” Test) at 3, 6 (primary outcome), and 12 months’ follow-up. Secondary outcomes were: level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures. Results The 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] y; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) y; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active as compared with UCP participants (mean difference = −198; 95% CI = −90 to −306) active minutes. At 6 months, between-group mean differences (95% CI) favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (−14.2 [−21 to −8]) seconds] and frailty levels (−5 [−8 to −1] points). At 12 months, the physical activity levels of Coach2Move participants further increased and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed. Conclusions This study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapeutic sessions compared with UCP. Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended. Impact This article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively in comparison with usual care physical therapy and, therefore, has application for physical therapists working with older adults in daily clinical practice. Lay summary Coach2Move is a new physical therapeutic approach for older adults. This manuscript describes how implementation of Coach2Move in daily clinical practice achieves better outcomes over a longer period of time against similar costs in comparison with regular physical therapy.

show abstract

Section: Methodsmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial

Heij¹,

Sweerts²,

Staal

et al. 2022

Physical Therapy

Self Cite

View full text Add to dashboard Cite

show abstract

Vascular flow limitations affecting the cervico-cranial region: Understanding ischaemia

Taylor¹,

Kerry²,

Mourad³

et al. 2023

Brazilian Journal of Physical Therapy

View full text Add to dashboard Cite

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

Heij¹,

Teerenstra²,

Sweerts³

et al. 2019

Physical Therapy

View full text Add to dashboard Cite

Background Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. Objective The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. Design, Setting, Participants, and Intervention A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. Measurements Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. Limitations An important limitation of the study design is the inability to blind treating therapists to study allocation. Discussion The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation.

show abstract

Reducing sample size by combining superiority and non-inferiority for two primary endpoints in the Social Fitness study

Cited by 3 publications

References 29 publications

Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial

Implementing a Personalized Physical Therapy Approach (Coach2Move) Is Effective in Increasing Physical Activity and Improving Functional Mobility in Older Adults: A Cluster-Randomized, Stepped Wedge Trial

Vascular flow limitations affecting the cervico-cranial region: Understanding ischaemia

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

Contact Info

Product

Resources

About