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临床试验/NCT03325049
NCT03325049终止不适用

The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT

Linkoeping University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
17
试验地点
1
主要终点
family functioning

研究概览

简要总结

Objective: We investigated the outcomes of a nurse-led family intervention, Health Promoting Conversations, which focused on family functioning and wellbeing in families with a critically ill member.

Study design: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families.

Outcome measures: The Health Promoting Conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the General Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey. Descriptive and analytical statistical methods were used to analyse the data.

详细描述

This randomized control trial (RCT) used a pre-test, post-test design with intervention and control groups.

In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.

Baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. Follow-up assessments were conducted 3 and 12 months after the intervention for both groups. Additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. The latter was calculated using the Charlson Comorbidity Index (Charlson et al., 1987).

The main outcome variables in this study were family functioning and family wellbeing. The following instruments were used in this study: 1) General Functioning (GF) sub-scale from the McMaster Family Assessment Device (FAD); 2) Family Sense of Coherence (F-SOC/F-KASAM); 3) Herth Hope Index (HHI); and 4) Medical Outcome Short-Form health survey (SF-36).

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
None

入排标准

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

入选标准

  • •patient age >18 years
  • •patient treated in the ICU for at least 96 hours
  • •at least one family member (age >15 years) interested in participating

排除标准

  • •or other severe psychiatric illnesses
  • •drug abuse
  • •difficulties in understanding or reading the Swedish language

研究组 & 干预措施

The health-promoting conversations

Experimental

In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.

干预措施: The health-promoting conversations (Behavioral)

Control Arm

Active Comparator

Usual Care

干预措施: Usual Care (Other)

结局指标

主要结局

family functioning

时间窗: up to 12 months

e GF is a 12-item scale designed to measure self-reported perceived overall 15 family functioning (Wright and Leahey, 2009, 2013). Each item is rated on a four-point 16 Likert scale: 'strongly agree' = 1, 'agree' = 2, 'disagree' = 3 and 'strongly disagree' = 4. The 17 scale scores ranges from 12 to 48, with lower scores indicating better family functioning. The 18 GF was translated into Swedish and has been pilot tested in Swedish samples, and the scale 19 has shown satisfactory reliability and acceptable validity of 0.90 (Bylund et al., 2015). The 20 reliability coefficient alpha was 0.45 in this study.

次要结局

未报告次要终点

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susanna Ågren

Head of the project

Linkoeping University

研究点 (1)

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