Conectando Corazones Intervention in Family Caregivers of an Older Adult With Dementia (NCT07695194) | Clinical Trial Compass
CompletedNot Applicable
Conectando Corazones Intervention in Family Caregivers of an Older Adult With Dementia
Colombia80 participantsStarted 2024-09-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial, called 'Conectando Corazones,' focused on family caregivers of older adults with dementia — how would my doctor know if I, as a caregiver, was struggling enough with my caregiving role to have benefited from something like this intervention?
2Since this trial has already been completed, is there any published data on whether the Conectando Corazones program actually improved how family caregivers felt in their role, and could my doctor help me find those results?
3Because this was a Phase NA study — meaning it wasn't testing a drug but rather a caregiving support program — does my doctor know of similar caregiver support programs that are currently active or available to me right now?
4The trial specifically measured 'weakness in the exercise of the family caregiver role' — what tools or assessments does my doctor use to evaluate whether I, as a caregiver, am coping adequately, and are there support resources they can refer me to based on that?
5Given that this trial is now completed and enrollment is closed, what does my doctor recommend as the best currently available support for family caregivers of someone with dementia, whether through a clinical program, community resource, or another active study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Exercise of the Family Caregiver Role
Timeframe: 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