Health-promoting Family Conversations and Open Heart Surgery -An Intervention Model for Families: The HeartFam Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 6
- 主要终点
- Family-Sense Of Coherence (F-SOC)
研究概览
简要总结
Elective open-heart surgery involves physical and psychological strain for the person undergoing surgery. Family plays a significant part in care before and after surgery, and the family has care needs of their own. Health services need to address the family-caregiver burden as an essential aspect of care. Different methods aiming at stress reduction and involvement of patients and family members in care exist. The evidence is conflicting concerning which way is the most effective. Health-promoting conversations are an intervention model promoting family well-being and alleviation of illness and illness-related suffering for the whole family.
Families´ in the intervention group in this trial will, before and after one family member's elective open-heart surgery, participate in Health-promoting conversations. Health-promoting conversation is an intervention model based on the Family Systems Nursing theory. The person undergoing surgery decides which family members should be asked to participate in 1-3 conversations whit a family nurse. Effects on postoperative recovery, health-related quality of life, stress, and patient and family involvement in care will be evaluated with patient- and family-reported outcome measures.
The aim is to evaluate Health-promoting conversation's effect on family wellbeing, functioning, and involvement in care. The cost-effectiveness of the intervention will also be evaluated.
The study will follow the ethical guidelines of the Declaration of Helsinki. The Swedish National Committee on Health Research Ethics reviewed and accepted the study in march 2020 (nr 2019-06315)
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients =/>18 years of age
- •undergoing elective, open-heart surgery
- •having a minimum of one family member willing to participate in Health-promoting conversations
- •Family members
- •Family member of a patient undergoing elective, open-heart surgery
- •willing to participate in Health-promoting conversations *=/> 15 years of age
排除标准
- •patient and family member:
- •Inability to speak or understand Swedish to the extent of giving informed consent
- •Cognitive and/or psychiatric disorder to the extent of not being able to give informed consent
结局指标
主要结局
Family-Sense Of Coherence (F-SOC)
时间窗: A statistically significant change in F-SOC from baseline at three months after hospital discharge between the trial patient groups.
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
次要结局
- RAND-36(12 month follow up)
- Cost-Effectiveness of Heath promoting conversations(12 month follow up)
- Family Involvement in Care Questionnaire (FICQ)(Family members only: 2 weeks after hospital discharge)
- Postoperative Recovery Profile (PRP)(12 month follow up)
- Family-Sense Of Coherence (F-SOC)(12 month follow up)
- General Functioning Scale (GFS)(12 month follow up)
- Family Hardiness Index (FHI)(12 month follow up)