Effectiveness of an educational nursing intervention on caring ability and burden in family caregivers of patients with chronic non-communicable diseases. A preventive randomized controlled clinical trial

A preventive controlled clinical trial was conducted with two comparison groups (intervention and control) in 2017. The inclusion criteria were to be aged 18 or over, be the caregiver of a patient with a chronic non-communicable disease (NCD) and the time devoted to caring was at least three months. Caregivers with difficulties in communication and those who could not receive the whole intervention were excluded. To meet the selection criteria, 34 family caregivers of patients with NCD were selected, who were users of a private tertiary hospital in Bucaramanga (Colombia).

Randomization.
To assign the intervention, on behalf of the project coordination center, a co-researcher of this study randomized family caregivers in balanced blocks to either the control group or intervention group, by using a list of random numbers generated in Excel.

Intervention.
The intervention consisted of the application of a four-topic workshop aimed at improving the family caregiver ability on knowledge, courage and patience, using a booklet designed by the Universidad Nacional de Colombia. This workshop was individually applied to each patient in a window of 3 hours at the hospital and was led by a nurse of the research team accompanied by a final year student of the nursing degree. The topics, objectives and activities are described in Table 1. Training related to the chronic pathology was provided to the control group, using educational support material designed by the research team. All participants of the control group were offered to have an intervention after the post-intervention surveys had been applied.

一项预防性对照临床试验于2017年进行，试验分为两组对比组（干预组和对照组）。纳入标准包括年龄在18岁及以上，作为患有慢性非传染性疾病（NCD）的患者的护理者，且护理时间至少为三个月。因沟通困难而无法参与以及无法接受完整干预的护理者被排除在外。为了符合选择标准，共选取了34位来自布卡拉曼加（哥伦比亚）一家私立三级医院的NCD患者家庭护理者。

随机分组。

为了分配干预措施，由项目协调中心的一名共同研究员通过使用在Excel中生成的随机数字列表，将家庭护理者随机分配到对照组或干预组，以实现平衡分组。

干预措施。

干预措施包括应用一个包含四个主题的工作坊，旨在提升家庭护理者在知识、勇气和耐心方面的能力，该工作坊由哥伦比亚国立大学设计的小册子提供支持。该工作坊以个体形式在医院内的三个小时时间段内对每位患者进行实施，由研究团队的一名护士和一名护理学最后一年级的学生共同指导。主题、目标和活动在表1中详细描述。对照组接受了与慢性病理相关的培训，使用研究团队设计的教育支持材料。所有对照组参与者均被邀请在干预后调查完成后接受干预。