Blakø Mitti, Christensen Anne Vinggaard, Højskov Ida Elisabeth, Palm Pernille, Berg Selina Kikkenborg
Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Department of Heart- and Lung Surgery, RT, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Pilot Feasibility Stud. 2023 Feb 6;9(1):22. doi: 10.1186/s40814-023-01255-9.
In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome, and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness are lacking.
To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.
A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up).
Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the 6 months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline and 1, 3, and 6 months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consultations will be based on middle-range theory of self-care.
Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors, and health outcomes will be evaluated in the intervention and the control group at baseline and 1, 3, 6, and 12 months.
The present study will contribute with knowledge on how to implement a feasible social support intervention targeting patients treated for cardiac disease who experience loneliness and, furthermore, investigate the preliminary effect on health behavior and health outcome in the early rehabilitation period.
The trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.
在接受心脏病治疗的患者中，孤独对健康行为、健康结局有负面影响，并会增加心脏疾病及全因死亡率风险。即便如此，在医疗保健研究中，针对经历孤独的患者的社会支持干预研究仍很匮乏。
确定针对经历孤独的心脏病治疗患者的个体化社会支持干预措施的可行性。
一项基于随机临床试验设计的可行性研究，按1:1随机分为6个月社会支持项目加常规护理（干预组）与常规护理（即基于常规指南的随访，对照组）。
根据高风险孤独工具被归类为高风险孤独的患者，在心脏病治疗后的6个月康复期将配备一名非正式照护者。非正式照护者将由患者从现有的社交网络或同伴中指定，具体取决于患者的偏好。干预措施的核心内容是通过在基线、第1、3和6个月进行护士咨询，增强和强化非正式照护者作为社会支持资源的能力。护士咨询的理论框架将基于自我护理的中程理论。
将根据预先定义的可行性标准，从可接受性和依从性方面评估可行性。将在基线、第1、3、6和12个月对干预组和对照组的患者报告结局、健康行为和健康结局进行干预的初步效果评估。
本研究将提供关于如何对经历孤独的心脏病治疗患者实施可行的社会支持干预措施的知识，此外，还将调查早期康复期对健康行为和健康结局的初步影响。
该试验于2022年8月18日在clinicaltrials.gov（NCT05503810）注册。
