Heart FailurePhase 2PLANCUIDARTENCT06309875
Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure
A Phase 2 study testing PLAN CUIDARTE and Conventional care in people with Heart Failure and Caregiver Burden, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Caregiver Burden, Discharge Plan
- What is being tested?
- PLAN CUIDARTE and Conventional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteColombia
- Study dates
- 25 Mar 2024to 12 Nov 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age who are hospitalized and admitted to the institution with a diagnosis of HF decompensation with a time of diagnosis greater than 6 months.
- Patients who are hemodynamically stable, without alteration of the state of consciousness.
Who cannot join
- HF patients who are hospitalized for cardiac transplantation,
- Who are under palliative management or who, at the time of discharge, have a formal
- Who have a designated formal caregiver or are discharged to an institution other than home.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Universidad de Caldas
Manizales, Caldas Department, 170004.
Claudia Marcela Vallejo, Mag, +573163614224, marcela.vallejo@ucaldas.edu.co
About this study
Official title: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure: Implementation of the Research Protocol.
According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.
The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HF
Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons.
Read the detailed description
Eligibility Criteria:
Inclusion criteria
- Patients over 18 years of age with a diagnosis of HF.
- Patients with HF who are hemodynamically stable.
- Patients with SPMSQ - PFERFFER of 0 - 4 errors or 5 errors, patient who has not received primary education.
- Patient with a PULSES of 6 to 11
Exclusion criteria
- Patients with heart failure with heart transplantation scheduled in the next 6 months.
- Patients requiring transfer to an intensive or intermediate care unit.
Outcome Measures:
- Primary: Caring competence.
- Secondary: Satisfaction with care
- Conditions
- Heart Failure, Caregiver Burden, Discharge Plan, Care Transitions, Nursing
- Being tested
- PLAN CUIDARTE, Conventional care
- Medical subject headings
- Heart Failure, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAN CUIDARTEOther
Description Plan Cuidarte
Conventional careOther
Description Conventional care
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Set of specific activities carried out by the health care team by the health care team at the time of hospital discharge of HF patients: the patients with HF: Receives: Other: Conventional care |
| PLAN CUIDARTE | Experimental | The "PLAN CUIDARTE" is an intervention aimed at addressing the hospital discharge of people with HF, based on the nursing theory of transitions of Afaf Meleis(46) and under the guidelines of Robin Whittemore for the systematic development of complex interventions for experimental type research in nursing. The PLAN CUIDARTE addresses the specific educational needs of HF patients, as established by the patients with HF, as established by international accreditation standards. Receives: Other: PLAN CUIDARTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Competence
capacity, ability and preparation of the patient or family caregiver to the patient or family caregiver to perform the task of caregiving(4), which is made up of the following five dimensions: knowledge five dimensions: knowledge, uniqueness, instrumental, enjoyment, anticipation and social relationship, uniqueness, instrumental, enjoyment, anticipation and social relationship.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Mar 2024 (estimated)
- Primary completion25 Jun 2024 (estimated)
- Study completion12 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test. The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Caldas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309875
- Sponsor's protocol ID
- ENF- 25-2018
- Acronym
- PLANCUIDARTE
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure: Implementation of the Research Protocol.
- ClinicalTrials.gov ID
- NCT06309875
- Acronym / sponsor ID
- PLANCUIDARTE / ENF- 25-2018
- Conditions
- Heart Failure, Caregiver Burden, Discharge Plan, Care Transitions, Nursing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Collaborators
- Universidad de Caldas
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 12 Nov 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.
The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HF
Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons.
Detailed description
Eligibility Criteria:
Inclusion criteria
- Patients over 18 years of age with a diagnosis of HF.
- Patients with HF who are hemodynamically stable.
- Patients with SPMSQ - PFERFFER of 0 - 4 errors or 5 errors, patient who has not received primary education.
- Patient with a PULSES of 6 to 11
Exclusion criteria
- Patients with heart failure with heart transplantation scheduled in the next 6 months.
- Patients requiring transfer to an intensive or intermediate care unit.
Outcome Measures:
- Primary: Caring competence.
- Secondary: Satisfaction with care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test. The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later)
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: Conventional careSet of specific activities carried out by the health care team by the health care team at the time of hospital discharge of HF patients: the patients with HF: |
| PLAN CUIDARTE | Experimental | Other: PLAN CUIDARTEThe "PLAN CUIDARTE" is an intervention aimed at addressing the hospital discharge of people with HF, based on the nursing theory of transitions of Afaf Meleis(46) and under the guidelines of Robin Whittemore for the systematic development of complex interventions for experimental type research in nursing. The PLAN CUIDARTE addresses the specific educational needs of HF patients, as established by the patients with HF, as established by international accreditation standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age who are hospitalized and admitted to the institution with a diagnosis of HF decompensation with a time of diagnosis greater than 6 months.
- Patients who are hemodynamically stable, without alteration of the state of consciousness.
Key exclusion criteria (3 listed)
- HF patients who are hospitalized for cardiac transplantation,
- Who are under palliative management or who, at the time of discharge, have a formal
- Who have a designated formal caregiver or are discharged to an institution other than home.
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 |
|---|---|---|
| PLAN CUIDARTEDescription Plan Cuidarte | Other | PLAN CUIDARTE |
| Conventional careDescription Conventional care | Other | Conventional |
Primary outcome
Care Competence
Time frame: 30 days
capacity, ability and preparation of the patient or family caregiver to the patient or family caregiver to perform the task of caregiving(4), which is made up of the following five dimensions: knowledge five dimensions: knowledge, uniqueness, instrumental, enjoyment, anticipation and social relationship, uniqueness, instrumental, enjoyment, anticipation and social relationship.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLAN CUIDARTE and Conventional care in people with Heart Failure and Caregiver Burden, 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 2 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandra Fuentes-Ramirez, DR (+573123722107, alejandra.fuentes@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Competence (time frame: 30 days). 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 13 Mar 2024.