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临床试验/NCT03788096
NCT03788096Unknown不适用

Peer Support for Post Intensive Care Syndrome Self-Management (PS-PICS)

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Social Network Index

研究概览

简要总结

A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support) intervention or usual care (control) group.

详细描述

Randomized participants will complete 4 study assessments: 1) baseline data at hospital discharge; 2) baseline data post-hospital discharge and before the start of the weekly peer support intervention; 3) post-intervention at the conclusion of the 90-day weekly peer support intervention; and 4) follow-up at 6-months post-hospital discharge. The weekly peer support intervention will be delivered by a small pool of critical illness survivor peers (mentors) recruited from the study site from previous research. Peer support mentors will be trained in peer support and MI, and will deliver 3 months of weekly MI interventions (phone-based) to CCI survivors randomized to the intervention group. Participants randomized to the usual care group will not receive the weekly peer support/MI intervention but will receive the usual discharge planning services currently provided at hospital discharge. Participants in both groups will be contacted by the research team for 4 telephone-based assessments. The design will allow us to test the feasibility and potential impact of the PS-PICS intervention on social relationship measures, depression and self-management. Data collection and analyses are guided by the Individual and Family Self-Management Theory. The Individual and Family Self-Management Theory illustrates the interaction of the process of self-management with risk and protective factors, and short-term and long-term outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age18 years or older
  • •ICU length of stay 8 days or longer
  • •expected to survive hospitalization with a discharge destination to home within 28 days of hospital discharge
  • •diagnosed with 2 or more chronic conditions.

排除标准

  • •death prior to hospital discharge
  • •enrollment in Hospice services at the time of hospital discharge
  • •non-communicative
  • •no access to telephone
  • •incarcerated

研究组 & 干预措施

PS-PICS Peer Support Intervention

Experimental

ICU mentors will be responsible for providing support to survivor participants randomized to the PS-PICS peer support intervention. Mentors will be trained in motivational interviewing techniques to engage mentees in goal setting and emotional management that is not readily accessible as part of discharge planning.

干预措施: Peer Support with Motivational Interviewing (Behavioral)

Usual Care Group

Placebo Comparator

A control intervention will be used to provide comparison data consistent with usual care (absence of structured peer support telephone intervention) to evaluate the impact of the PS-PICS peer support intervention.

干预措施: Usual Care Group (Behavioral)

结局指标

主要结局

Social Network Index

时间窗: 3 months post-intervention

Social Network Index (SNI) to measure social relationships. The scale range is 0-12. The total score will be reported. The maximum total score is 12. Higher values represent a broader diversity of social networks and are classified as a better outcome.

次要结局

  • Center for Epidemiologic Studies Depression Scale (CES-D)(3 months post-intervention)
  • Patient Activation Measure(3 months post-intervention)
  • Social Network Index(1-week Post-intervention)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale(3 months post-intervention)
  • Short Form-36 (SF-36)(3 months post-intervention)
  • Center for Epidemiologic Studies Depression Scale (CES-D)(1-week Post-intervention)
  • Patient Activation Measure(1-week Post-intervention)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale(1-week Post-intervention)
  • Short Form-36 (SF-36)(1-week Post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valerie Danesh

Assistant Professor

University of Texas at Austin

研究点 (1)

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