Systematized Nursing Intervention to Strengthen the Family Caregiver Role of an Older Adult With Dementia: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Exercise of the Family Caregiver Role
研究概览
简要总结
The objective of this randomized clinical trial, with pre-test and post-test measurements in an experimental group and a comparison group, was to evaluate the effect of the systematized nursing intervention "Conectando Corazones" (Connecting Hearts) in strengthening the exercise of the family caregiver role among family caregivers of older adults with dementia, using the Family Caregiver Role Adoption instrument for caregivers of persons with chronic illness.
Main Hypothesis:
Is there a difference in family caregiver role performance between family caregivers of older adults with dementia who receive a systematized nursing intervention and those who receive conventional care? The researchers compared the exercise of the role (responses, organization, and tasks) of family caregivers of older adults with dementia, before and after receiving either the systematized nursing intervention or conventional care.
Participants were required to:
- Undergo characterization, in both the experimental and comparison groups, based on the Caregiving Dyad Characterization Form (GCPC-UN-D), designed by the Chronic Patient Care Research Group of the Universidad Nacional de Colombia.
- Complete the pre-test simultaneously in both groups (measurement of family caregiver role performance using the ROL instrument).
- The experimental group received the systematized nursing intervention to strengthen the exercise of the family caregiver role, consisting of 3 modules with 2 sessions each. Sessions were 2 hours long, for a total of 6 sessions (12 hours); 3 in-person sessions and 3 independent work sessions (with materials and educational aids provided).
- The comparison group received conventional care.
- Both groups then simultaneously completed the post-test using the same instrument.
详细描述
This is a two-phase nursing intervention study. The objective was to evaluate the effect of a systematized nursing intervention designed to strengthen the exercise of the family caregiver role of an older adult with dementia residing in Huila, Colombia, 2024-2025.
Phase 1 (Methodological): A systematized nursing intervention, "Conectando Corazones," was designed following the guidelines of Sidani and Braden, incorporating theoretical, empirical, and experiential evidence. Dyad characterization data (GCPC-UN-D instrument) were analyzed descriptively (frequencies for qualitative variables; central tendency and dispersion measures for quantitative variables) using IBM SPSS version 31, separately for the intervention and comparison groups, to verify baseline homogeneity. The intervention was subsequently validated by a panel of seven experts, who assessed clarity, coherence, relevance, and sufficiency. Content validity ratios (CVR) by dimension and an overall content validity index (CVI) were calculated using the Lawshe method as modified by Tristán-López (2008), with values above 0.75 considered acceptable. Fleiss' Kappa was calculated to assess inter-rater agreement, interpreted according to the Landis and Koch (1977) scale.
Phase 2 (Effect Evaluation): The effect of the "Conectando Corazones" intervention was evaluated through a randomized clinical trial with pre-test/post-test, intragroup and intergroup comparisons. Data from the ROL instrument (family caregiver role adoption) were analyzed in IBM SPSS version 31. As normality tests indicated a non-normal distribution, nonparametric tests were used: the Sign test and Wilcoxon signed-rank test for intragroup (pre-post) comparisons, and the Mann-Whitney U test and Kolmogorov-Smirnov test for intergroup comparisons between the experimental and comparison groups (Polit & Beck, 2017).
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
- 是
入选标准
- •Being the primary family caregiver of an older adult aged 60 years or older with dementia.
- •Having served as a caregiver for more than 3 months.
- •Caring for an older adult with dementia at home.
- •Being 18 years of age or older.
- •Having adequate cognitive and communication abilities to participate in the study
排除标准
- •Caring for a person with dementia who is hospitalized.
- •Having to institutionalize the older adult with dementia in a long-term care facility during the course of the study.
- •Loss of the family caregiver or the older adult with dementia during the course of the study.
结局指标
主要结局
Exercise of the Family Caregiver Role
时间窗: Pre-test at baseline (day of intervention initiation) and post-test at 4 weeks, after completion of the intervention sessions delivered during weeks 1-3
Exercise of the family caregiver role of an older adult with dementia, assessed using the Role Adoption instrument (Responses, Organization, and Tasks) developed by Universidad Nacional de Colombia. The instrument evaluates the caregiver's role performance across the dimensions of responses, organization, and caregiving tasks
次要结局
未报告次要终点