Nighttime Postural Care: Caregiver Training Program and Outcome Measure Feasibility
1 other identifier
interventional
38
1 country
1
Brief Summary
This experimental study investigated the feasibility of a sleep care positioning training protocol by comparing two educational interventions using a randomized control design. The overarching Population Intervention Comparison Outcomes (PICO) question was: Is the training protocol feasible for use in training caregivers? Question one includes the following sub questions: A. Is there a difference in perceived competence to implement aspects of nighttime postural care intervention or observed ability to position the person in a sleep system between caregivers receiving one training program versus another? B. Does the training protocol prepare caregivers to implement nighttime postural care (NTPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedMarch 8, 2021
January 1, 2021
4 months
January 22, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Baseline Sleep Care Positioning Questionnaire
Perceived competence questionnaire with 4-pt. ratings of knowledge, ability and confidence for nighttime postural care research, risk factor monitoring, sleep system types / set-up, positioning a person, and measuring outcomes.
Completed immediately before training/educational intervention. Same day as training.
Post Sleep Care Positioning Program Questionnaire
Perceived competence questionnaire with 4-pt. ratings of knowledge, ability and confidence for nighttime postural care research, risk factor monitoring, sleep system types / set-up, positioning a person, and measuring outcomes.
Completed immediately after training / educational intervention. Same day as training.
Post Simulation Sleep Care Positioning Program Questionnaire
Perceived competence questionnaire with 4-pt. ratings of knowledge, ability and confidence for nighttime postural care research, risk factor monitoring, sleep system types / set-up, positioning a person, and measuring outcomes.
Completed immediately after simulation activity, after positioning a person in a sleep system. Same day as training.
Secondary Outcomes (1)
Simulation Observation Instrument
Completed after training and post-training questionnaire. Same day as training.
Study Arms (2)
Sleep Care Positioning Training Program GRP1
EXPERIMENTALA sleep care positioning lesson created by a University's postural-care scholars using Camtasia® video creation software with modules on evidence for night-time postural care, risk factor monitoring, sleep system types and set up, positioning methods, and outcome measures. This lesson consisted of interactive videos embedded with learning checkpoints. All videos included narration and closed captioning. The following link contains the videos which were modified post-study to reflect some of the participant's feedback: https://stkatentpc.weebly.com/
Sleep Care Positioning Training Program GRP2
ACTIVE COMPARATORA sleep care positioning lesson created by a research assistant along with the principal investigator with modules on evidence for night-time postural care, risk factor monitoring, sleep system types and set up, positioning methods, and outcome measures. This lesson consisted of primarily written summary statements and links to freely available web-based information. Most of this lesson's modules included written information that the participant would need to read with the exception of the positioning methods modules. For the positioning module, participants were provided with links to manufacturers' websites which contained video clips on how to place postural supports.
Interventions
Video-based tutorial covering six nighttime postural care topic areas which contained narration and closed captioning. This 2-hour online training program was delivered in a University classroom via D2L Brightspace.
Web-link based tutorial covering six nighttime postural care topic areas which contained mostly written content. This self-paced online training program was delivered in a University classroom via D2L Brightspace.
Eligibility Criteria
You may qualify if:
- Professional and non-professional caregivers of children with movement disorders or cerebral palsy.
You may not qualify if:
- Caregivers without knowledge of sleep habits and routines of persons with such diagnoses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Catherine Universitylead
- University of Minnesotacollaborator
Study Sites (1)
St. Catherine University
Saint Paul, Minnesota, 55105, United States
Related Publications (1)
Hutson, J.A. (2020). Nighttime Postural Care Sleep-Based Outcome Measures and Education: Preparing Care Providers of Children with Cerebral Palsy (Doctoral Dissertation). University of Minnesota, Available from ProQuest Dissertations Publishing. (Dissertation Number: 27741484)
BACKGROUND
Related Links
- The sleep care positioning training program (Lesson A) which was provided to Group 1. The version found at this site contains some edits based on the feedback provided by participants during the research study.
- Jennifer Hutson's dissertation which contains a detailed description of the study and its outcomes (information about this study is primarily contained within chapters 3 \& 4 of the dissertation).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Schmitt
St. Catherine University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators hypothesized that caregivers would be more competent after lesson A (as compared with lesson B). Because of this participants were masked from knowing which lesson they'd received and were not informed about investigators hypothesis. The clinician's responsible for measuring participants' observed competence for positioning a person post-training were not informed of participant's assigned lesson. Participants were instructed to not discuss their lesson or lesson details with the clinicians' measuring those outcomes. The research assistant completed randomization and academic technology personnel registered participants into their lesson to ensure the principal investigator was not informed of participant's assigned lesson.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
March 8, 2021
Study Start
June 1, 2018
Primary Completion
September 22, 2018
Study Completion
September 22, 2018
Last Updated
March 8, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- January, 2021 - January 2022
- Access Criteria
- Please email any requests for additional information to Jennifer Hutson at jahutson@stkate.edu
Sharing plan will be determined based on researcher requests. The following could potentially be shared: blank informed consent document (attached to this registry), protocol submitted to IRB (attached to this registry), blank questionnaires and simulation observation instruments and de-identified raw numerical data from questionnaire and simulation observation instrument.