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Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial.

Publication ,  Journal Article
Pastva, AM; Duncan, PW; Reeves, GR; Nelson, MB; Whellan, DJ; O'Connor, CM; Eggebeen, JD; Hewston, LA; Taylor, KM; Mentz, RJ; Rosenberg, PB ...
Published in: Contemp Clin Trials
January 2018

INTRODUCTION: Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older adults. Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial is a multi-site clinical trial to determine if physical rehabilitation intervention in older patients with ADHF improves physical function and reduces rehospitalizations. The REHAB-HF intervention aims to improve functional performance utilizing reproducible and progressive exercises that are individually tailored to the patient's physiological and physical capabilities. Fidelity of the intervention is essential to the trial's integrity and success. Maintaining fidelity is challenged by the complex, multi-domain design of the intervention implemented across multiple sites and delivered to an older, heterogeneous participant pool with severe underlying disease and multi-morbidity. METHODS/DESIGN: Given the dynamic nature of the REHAB-HF intervention, rigorous fidelity strategies were formulated. In this paper we summarize the specific strategies that REHAB-HF is using to meet the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup recommendations in 5 key areas: 1) ensuring the intervention dose is consistent across participants, 2) standardizing interventionist training, 3) monitoring intervention delivery, 4) evaluating participants' understanding of information provided, and 5) ensuring that participants use the skills taught in the intervention. DISCUSSION: Effective intervention fidelity strategies are essential to the reliability and validity of physical function intervention trials. The REHAB-HF trial has developed comprehensive, specific strategies to ensure intervention fidelity despite a challenging study population and a complex intervention to meet NIH recommendations. This experience provides a strong working model for future physical function intervention trials.

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2018

Volume

64

Start / End Page

118 / 127

Location

United States

Related Subject Headings

  • Single-Blind Method
  • Research Design
  • Reproducibility of Results
  • Quality of Life
  • Public Health
  • Postural Balance
  • Physical Therapy Modalities
  • Middle Aged
  • Humans
  • Heart Failure
 

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Pastva, A. M., Duncan, P. W., Reeves, G. R., Nelson, M. B., Whellan, D. J., O’Connor, C. M., … Kitzman, D. W. (2018). Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial. Contemp Clin Trials, 64, 118–127. https://doi.org/10.1016/j.cct.2017.10.014
Pastva, Amy M., Pamela W. Duncan, Gordon R. Reeves, M Benjamin Nelson, David J. Whellan, Christopher M. O’Connor, Joel D. Eggebeen, et al. “Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial.Contemp Clin Trials 64 (January 2018): 118–27. https://doi.org/10.1016/j.cct.2017.10.014.
Pastva AM, Duncan PW, Reeves GR, Nelson MB, Whellan DJ, O’Connor CM, et al. Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial. Contemp Clin Trials. 2018 Jan;64:118–27.
Pastva, Amy M., et al. “Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial.Contemp Clin Trials, vol. 64, Jan. 2018, pp. 118–27. Pubmed, doi:10.1016/j.cct.2017.10.014.
Pastva AM, Duncan PW, Reeves GR, Nelson MB, Whellan DJ, O’Connor CM, Eggebeen JD, Hewston LA, Taylor KM, Mentz RJ, Rosenberg PB, Kitzman DW. Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial. Contemp Clin Trials. 2018 Jan;64:118–127.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2018

Volume

64

Start / End Page

118 / 127

Location

United States

Related Subject Headings

  • Single-Blind Method
  • Research Design
  • Reproducibility of Results
  • Quality of Life
  • Public Health
  • Postural Balance
  • Physical Therapy Modalities
  • Middle Aged
  • Humans
  • Heart Failure