Implementation of a randomized controlled trial on an inpatient stroke rehabilitation unit: Lessons learned.
Implementation
Inpatients
Randomized controlled trials
Rehabilitation
Stroke
Virtual reality
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
25
11
2019
revised:
09
03
2020
accepted:
22
03
2020
entrez:
4
7
2020
pubmed:
4
7
2020
medline:
4
7
2020
Statut:
epublish
Résumé
The objective of this manuscript is to present challenges and solutions that arose during a mid-sized single-site RCT of a rehabilitation intervention performed in an inpatient stroke rehabilitation setting. Seventy-six participants from an inpatient stroke rehabilitation unit were randomized to experimental and control groups. All participants did 30-45 min of virtual reality (VR) daily for 10-12 sessions. The experimental group did VR targeting sitting balance while the control group did VR with limited arm movement. Challenges during the implementation of the RCT were documented and strategies to mitigate them were applied. Challenges were placed into five categories:1. Recruitment. Our recruitment procedures required multiple steps prior to initiating direct patient contact; one solution would be to have patients consent to be approached about research upon admission to the inpatient unit.2. Patient-specific Issues. Fatigue, pain, vision problems and engagement were managed through scheduling, increasing the workload slowly and personalized modifications to the VR.3./4. Scheduling and Staffing. Recruitment and attendance at VR sessions were maximized through good communication, flexibility and cooperation, between research staff, clinical staff, volunteers, students and participants.5. Technology. Because hospital internet service was poor, a mobile internet data plan was purchased to ensure the system's reliability. We have identified challenges in delivering a rehabilitation intervention on an inpatient stroke rehabilitation unit and some of the measures taken to surmount these challenges. Through good planning, flexibility and collaboration, almost all of the challenges were successfully addressed. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02285933.
Sections du résumé
BACKGROUND/AIMS
OBJECTIVE
The objective of this manuscript is to present challenges and solutions that arose during a mid-sized single-site RCT of a rehabilitation intervention performed in an inpatient stroke rehabilitation setting.
METHODS
METHODS
Seventy-six participants from an inpatient stroke rehabilitation unit were randomized to experimental and control groups. All participants did 30-45 min of virtual reality (VR) daily for 10-12 sessions. The experimental group did VR targeting sitting balance while the control group did VR with limited arm movement. Challenges during the implementation of the RCT were documented and strategies to mitigate them were applied.
RESULTS
RESULTS
Challenges were placed into five categories:1. Recruitment. Our recruitment procedures required multiple steps prior to initiating direct patient contact; one solution would be to have patients consent to be approached about research upon admission to the inpatient unit.2. Patient-specific Issues. Fatigue, pain, vision problems and engagement were managed through scheduling, increasing the workload slowly and personalized modifications to the VR.3./4. Scheduling and Staffing. Recruitment and attendance at VR sessions were maximized through good communication, flexibility and cooperation, between research staff, clinical staff, volunteers, students and participants.5. Technology. Because hospital internet service was poor, a mobile internet data plan was purchased to ensure the system's reliability.
CONCLUSIONS
CONCLUSIONS
We have identified challenges in delivering a rehabilitation intervention on an inpatient stroke rehabilitation unit and some of the measures taken to surmount these challenges. Through good planning, flexibility and collaboration, almost all of the challenges were successfully addressed.
CLINICAL TRIAL REGISTRATION NUMBER
BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02285933.
Identifiants
pubmed: 32617429
doi: 10.1016/j.conctc.2020.100563
pii: S2451-8654(20)30047-8
pii: 100563
pmc: PMC7322803
doi:
Banques de données
ClinicalTrials.gov
['NCT02285933']
Types de publication
Journal Article
Langues
eng
Pagination
100563Informations de copyright
© 2020 The Authors.
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