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Completed

NCT Number: NCT07695194

Conectando Corazones Intervention in Family Caregivers of an Older Adult With Dementia

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Music Park Library, Neiva, Huila Rivera Public Utilities, Rivera, Huila.

Neiva, Huila Department, 410001, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Intervention provided to the experimental group

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.

Other names: Intervention provided to the comparison group

Primary outcomes

  1. Exercise of the Family Caregiver Role

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de la Sabana

Other

Registry information

Official study title

Systematized Nursing Intervention to Strengthen the Family Caregiver Role of an Older Adult With Dementia: A Randomized Clinical Trial.

Acronym: CONNECTING-FC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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