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临床试验/NCT04787081
NCT04787081已完成不适用

Nighttime Postural Care: Caregiver Training Program and Outcome Measure Feasibility

St. Catherine University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Post Sleep Care Positioning Program Questionnaire

研究概览

简要总结

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).

详细描述

Target Population

Investigators planned to recruit a convenience sample of 40 adult participants identified as professional or non-professional care providers (primarily from two community organizations that specialize in serving clients with CP). Care providers of children (aged 6-12) with severe CP (those with limited ability to move and/or whom require use of a wheelchair) were the primary target population, since this matches the intended sample of a future intervention study. However caregivers of children outside of the 6-12 age range whom were candidates for NTPC and had similar mobility limitations as those with severe CP would not be excluded. Professional care providers could be nurses, occupational and physical therapists, assistive technology providers, etc. Non-professional care providers could be family members, care attendants, etc. Only individuals with knowledge of the child's sleep habits or routines were to be included in the study

Investigators used a mixed methods double-blind parallel group design, randomly assigning a consecutive sample of adults to an educational intervention (Lesson A or Lesson B).

Participant Recruitment

Investigators emailed flyers, recruiting participants from clinics serving persons with CP and universities educating healthcare providers and included professional and non-professional caregivers of persons with movement disorders, primarily CP with knowledge of a child's sleep habits and routines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Professional and non-professional caregivers of children with movement disorders or cerebral palsy.

排除标准

  • Caregivers without knowledge of sleep habits and routines of persons with such diagnoses

结局指标

主要结局

Post Sleep Care Positioning Program Questionnaire

时间窗: Completed immediately after training / educational intervention. Same day as training.

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.

Baseline Sleep Care Positioning Questionnaire

时间窗: Completed immediately before training/educational intervention. Same day as training.

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.

Post Simulation Sleep Care Positioning Program Questionnaire

时间窗: Completed immediately after simulation activity, after positioning a person in a sleep system. Same day as training.

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.

次要结局

  • Simulation Observation Instrument(Completed after training and post-training questionnaire. Same day as training.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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