Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Comprised of family caregivers of older adults with dementia, residing in Huila, who met the study's inclusion criteria, were randomly assigned, and were exposed to the systematized nursing intervention designed in this study. |
|
| Comparison group | Active Comparator | Comprised of family caregivers of older adults with dementia, residing in Huila, who met the study's inclusion criteria, were randomly assigned, and received conventional or usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conectando corazones | Behavioral | "Conectando Corazones" is a systematized nursing intervention grounded in Imogene King's Theory of Goal Attainment and the ROL instrument framework, aimed at strengthening the family caregiver role in caregivers of older adults with dementia by addressing the personal, interpersonal, and social systems involved in caregiving. The intervention targets the caregiver's tasks, responses, and organization related to the caregiving role, seeking to preserve or improve role performance through strengthening caregiving conditions, personal capacity, support networks, and goal attainment in the caregiving experience. It was delivered in a HyFlex format (in-person and/or virtual, with digital tele-support), structured in 3 modules of 2 sessions each (6 sessions total: 3 in-person and 3 independent work sessions), 2 hours per session, for a total of 12 hours. Sessions were delivered at a rate of one module per week over a 4-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise of the Family Caregiver Role | 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 | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jasleidy Lasso Conde, MSN | Universidad de la Sabana | Principal Investigator |
| Clara B Sanchez Herrera, MSN | Universidad de la Sabana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Music Park Library, Neiva, Huila Rivera Public Utilities, Rivera, Huila. | Neiva | Huila Department | 410001 | Colombia |
The informed consent approved by the Ethics Committee (Minutes No. 009, June 17, 2024) provides for the confidentiality of personal data and its use exclusively for the purpose of publishing aggregate results, without including a clause authorizing the sharing of individual participant data with third-party researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
This study used a two-arm parallel randomized controlled trial design. Forty family caregivers were allocated to the experimental group, who received the "Conectando Corazones" intervention, and forty were allocated to the comparison group. The intervention was developed following the Sidani and Braden framework for nursing intervention design, integrating a theoretical component (King's Theory of Goal Attainment and the ROL instrument), an empirical component (based on prior literature review findings), and an experiential component (derived from four focus groups with 22 family caregivers describing their role experience)
Not provided
Not provided
Not provided
Not provided
|
|
| Conventional intervention | Other | Basic telephone-based support service for family caregivers of older adults with dementia, aimed at facilitating access to available biopsychosocial and spiritual support services according to caregiver needs. The service provides basic guidance to help caregivers manage care-related tasks, including clarifying therapeutic guidelines given by neurologists or other treating therapists, and answering basic questions about oral medication administration, medical exams, specialized appointments, administrative procedures, or general recommendations. Components are delivered via telephone and WhatsApp. Caregivers referred to available support services are informed of where to go in person if needed. Phone calls are received 5 days per week during business hours (8:00-12:00 and 14:00-18:00), and WhatsApp messages are sent during morning hours. |
|
|
| D001523 | Mental Disorders |