Coronary Artery DiseaseADAPT-CABGNCT07576569
Nursing Intervention for Adaptation After Myocardial Revascularization
A study testing Nursing Intervention Program in people with Coronary Artery Disease and Myocardial Revascularization, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
Introduction: Myocardial revascularization is an essential procedure for patients with cardiovascular disease. Its recovery in the outpatient setting involves significant challenges for both the patient and the caregiver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Revascularization, Postoperative Recovery After Cardiac Surgery
- What is being tested?
- Nursing Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older who have undergone myocardial revascularization surgery, completed the immediate postoperative in-hospital period without major complications, and have been discharged for outpatient management according to institutional protocols
- Patients who, at the time of discharge, do not require ventilatory support, invasive hemodynamic support, or continuous monitoring, and present documented clinical stability
- Presence of an identified primary caregiver actively involved in the home care process during the outpatient postoperative period
- Preserved cognitive capacity in both patient and caregiver, allowing understanding of instructions, participation in the intervention, and completion of assessment instruments
- Written informed consent provided by both patient and caregiver
Who cannot join
- Patients presenting severe postoperative complications, such as deep surgical site infection, persistent hemodynamic instability, major neurological events, or readmission to the intensive care unit at the start of the intervention Patients with moderate to severe cognitive impairment, decompensated psychiatric disorders, or neurological conditions that limit understanding, communication, or active participation
- Caregivers with physical, cognitive, or emotional limitations that compromise the effective performance of the caregiving role during the follow-up period
- Patients without a clearly identified support network or without an available primary caregiver to participate in the study
- Concurrent participation in other clinical, educational, or psychosocial intervention studies that may interfere with the proposed intervention
- Language or cultural barriers that prevent understanding of the intervention content or interaction with the research team, without adequate mediation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preliminary Effectiveness of a Nursing Intervention Aimed at Improving Adaptation in Patients and Their Caregivers During the Outpatient Postoperative Period Following Myocardial Revascularization
Introduction: Myocardial revascularization is an essential procedure for patients with cardiovascular disease. Its recovery in the outpatient setting involves significant challenges for both the patient and the caregiver. This recovery phase may generate physical, emotional, and psychological complications that require an effective adaptation process of the patient-caregiver dyad to ensure successful recovery and improved quality of life.
Objective: To evaluate the preliminary effectiveness of a nursing intervention aimed at improving adaptation in the patient-caregiver dyad during the outpatient postoperative period following myocardial revascularization, compared with usual care, in Bucaramanga during the period 2026-2027.
Read more
Materials and Methods: A pilot randomized controlled trial will be conducted to develop and evaluate a novel nursing intervention aimed at promoting adaptation in patients undergoing outpatient postoperative myocardial revascularization and their caregivers. The intervention will be designed and its feasibility, acceptability, and preliminary effectiveness will be assessed. Data analysis will be performed using descriptive and inferential statistical methods, considering the distribution and behavior of the data.
Expected Results: The study is expected to assess the preliminary effectiveness of the proposed intervention through the integration of theoretical and empirical components.
- Conditions
- Coronary Artery Disease, Myocardial Revascularization, Postoperative Recovery After Cardiac Surgery, Nursing Care
- Being tested
- Nursing Intervention Program, Usual Care
- Keywords
- Myocardial Revascularization, Nursing Intervention, Patient-Caregiver Dyad, Adaptation, Postoperative Recovery, Cardiovascular Disease, Randomized Controlled Trial, Outpatient Care
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Intervention ProgramBehavioural
Structured nursing intervention focused on improving adaptation in the patient-caregiver dyad through education, emotional support, and follow-up care.
Usual CareOther
Participants will receive standard postoperative care without the structured nursing intervention.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Intervention | Experimental | Participants will receive a structured nursing intervention based on the Roy Adaptation Model, including education, emotional support, and follow-up during the 30-day outpatient postoperative period following myocardial revascularization. Receives: Behavioral: Nursing Intervention Program |
| Usual Care | Active comparator | Participants will receive standard postoperative care without the structured nursing intervention. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation level in the patient-caregiver dyad
Adaptation will be assessed using validated instruments that measure dimensions related to the Roy Adaptation Model, including physiological, self-concept, role function, and interdependence domains in both patient and caregiver.
Measured: Baseline and 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startJan 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an experimental group receiving a structured nursing intervention and a control group receiving usual care. The intervention will be delivered over a 30-day outpatient postoperative period following myocardial revascularization. Outcomes will be assessed at baseline and after the intervention period to compare effectiveness between groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvarez Yañez, Principal investigator, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576569
- Sponsor's protocol ID
- ENFPHD-16-2026
- Acronym
- ADAPT-CABG
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Effectiveness of a Nursing Intervention Aimed at Improving Adaptation in Patients and Their Caregivers During the Outpatient Postoperative Period Following Myocardial Revascularization
- ClinicalTrials.gov ID
- NCT07576569
- Acronym / sponsor ID
- ADAPT-CABG / ENFPHD-16-2026
- Conditions
- Coronary Artery Disease, Myocardial Revascularization, Postoperative Recovery After Cardiac Surgery, Nursing Care
- Keywords
- Myocardial Revascularization, Nursing Intervention, Patient-Caregiver Dyad, Adaptation, Postoperative Recovery, Cardiovascular Disease, Randomized Controlled Trial, Outpatient Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 May 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.
Introduction: Myocardial revascularization is an essential procedure for patients with cardiovascular disease. Its recovery in the outpatient setting involves significant challenges for both the patient and the caregiver. This recovery phase may generate physical, emotional, and psychological complications that require an effective adaptation process of the patient-caregiver dyad to ensure successful recovery and improved quality of life.
Objective: To evaluate the preliminary effectiveness of a nursing intervention aimed at improving adaptation in the patient-caregiver dyad during the outpatient postoperative period following myocardial revascularization, compared with usual care, in Bucaramanga during the period 2026-2027.
Materials and Methods: A pilot randomized controlled trial will be conducted to develop and evaluate a novel nursing intervention aimed at promoting adaptation in patients undergoing outpatient postoperative myocardial revascularization and their caregivers. The intervention will be designed and its feasibility, acceptability, and preliminary effectiveness will be assessed. Data analysis will be performed using descriptive and inferential statistical methods, considering the distribution and behavior of the data.
Expected Results: The study is expected to assess the preliminary effectiveness of the proposed intervention through the integration of theoretical and empirical components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: an experimental group receiving a structured nursing intervention and a control group receiving usual care. The intervention will be delivered over a 30-day outpatient postoperative period following myocardial revascularization. Outcomes will be assessed at baseline and after the intervention period to compare effectiveness between groups.
| Arm | Type | Receives |
|---|---|---|
| Nursing Intervention | Experimental | Behavioral: Nursing Intervention ProgramParticipants will receive a structured nursing intervention based on the Roy Adaptation Model, including education, emotional support, and follow-up during the 30-day outpatient postoperative period following myocardial revascularization. |
| Usual Care | Active comparator | Other: Usual CareParticipants will receive standard postoperative care without the structured nursing intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older who have undergone myocardial revascularization surgery, completed the immediate postoperative in-hospital period without major complications, and have been discharged for outpatient management according to institutional protocols
- Patients who, at the time of discharge, do not require ventilatory support, invasive hemodynamic support, or continuous monitoring, and present documented clinical stability
- Presence of an identified primary caregiver actively involved in the home care process during the outpatient postoperative period
- Preserved cognitive capacity in both patient and caregiver, allowing understanding of instructions, participation in the intervention, and completion of assessment instruments
- Written informed consent provided by both patient and caregiver
Key exclusion criteria (5 listed)
- Patients presenting severe postoperative complications, such as deep surgical site infection, persistent hemodynamic instability, major neurological events, or readmission to the intensive care unit at the start of the intervention Patients with moderate to severe cognitive impairment, decompensated psychiatric disorders, or neurological conditions that limit understanding, communication, or active participation
- Caregivers with physical, cognitive, or emotional limitations that compromise the effective performance of the caregiving role during the follow-up period
- Patients without a clearly identified support network or without an available primary caregiver to participate in the study
- Concurrent participation in other clinical, educational, or psychosocial intervention studies that may interfere with the proposed intervention
- Language or cultural barriers that prevent understanding of the intervention content or interaction with the research team, without adequate mediation
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 |
|---|---|---|
| Nursing Intervention ProgramStructured nursing intervention focused on improving adaptation in the patient-caregiver dyad through education, emotional support, and follow-up care. | Behavioural | Nursing Intervention |
| Usual CareParticipants will receive standard postoperative care without the structured nursing intervention. | Other | Usual Care |
Primary outcome
Adaptation level in the patient-caregiver dyad
Time frame: Baseline and 30 days post-discharge
Adaptation will be assessed using validated instruments that measure dimensions related to the Roy Adaptation Model, including physiological, self-concept, role function, and interdependence domains in both patient and caregiver.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Alvarez Yañez principal investigator
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 Nursing Intervention Program in people with Coronary Artery Disease and Myocardial Revascularization, 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 5 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: opening soon, as of the sponsor's last update on 8 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Débora Milena Alvarez Yañez, PhD(c) (+57 3112323289, deboraalya@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation level in the patient-caregiver dyad (time frame: Baseline and 30 days post-discharge). 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 8 May 2026.