DementiaCONNECTING-FCNCT07695194
Conectando Corazones Intervention in Family Caregivers of an Older Adult With Dementia
A study testing Conectando corazones and Conventional intervention in people with Dementia and Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia, run by Universidad de la Sabana at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia
- What is being tested?
- Conectando corazones and Conventional intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 2 Sep 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Music Park Library, Neiva, Huila Rivera Public Utilities, Rivera, Huila.
Neiva, Huila Department, 410001
About this study
Official title: Systematized Nursing Intervention to Strengthen the Family Caregiver Role of an Older Adult With Dementia: A Randomized Clinical Trial.
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:
Read more
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.
Read the detailed description
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).
- Conditions
- Dementia, Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia
- Being tested
- Conectando corazones, Conventional intervention
- Keywords
- Caregivers, Dementia, Alzheimer, Nursing Care, Role
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conectando corazonesBehavioural
Also called Intervention provided to the experimental group
"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.
Conventional interventionOther
Also called Intervention provided to the comparison group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start2 Sep 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasleidy Lasso Conde, MSN, Principal investigator, Universidad de la SabanaClara B Sanchez Herrera, MSN, Study director, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695194
- Sponsor's protocol ID
- Conectando Corazones
- Acronym
- CONNECTING-FC
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematized Nursing Intervention to Strengthen the Family Caregiver Role of an Older Adult With Dementia: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07695194
- Acronym / sponsor ID
- CONNECTING-FC / Conectando Corazones
- Conditions
- Dementia, Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia
- Keywords
- Caregivers, Dementia, Alzheimer, Nursing Care, Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Conectando corazonesComprised 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 | Other: Conventional interventionComprised 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conectando corazonesAlso: Intervention provided to the experimental group"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. | Behavioural | Experimental group |
| Conventional interventionAlso: Intervention provided to the comparison groupBasic 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 | Comparison group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasleidy Lasso Conde, MSN principal investigator
Universidad de la Sabana
Clara B Sanchez Herrera, MSN study director
Universidad de la Sabana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conectando corazones and Conventional intervention in people with Dementia and Weakness in the Exercise of the Family Caregiver Role of Older Adults With Dementia, run by Universidad de la Sabana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.