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

NCT07695194 | Completed

• 1 other identifier: Conectando Corazones
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia

Keywords

Caregivers; Dementia; Alzheimer; Nursing Care; Role

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Conectando corazones

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.

Other: Conventional intervention

Interventions

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.

Also known as: Intervention provided to the comparison group

Comparison group

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.

Also known as: Intervention provided to the experimental group

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

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

Neiva, Huila Department, 410001, Colombia

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jasleidy Lasso Conde, MSN

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

• Clara B Sanchez Herrera, MSN

  Universidad de la Sabana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: September 2, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)