Education, NursingNCT05300880
Health Coaching With Hospitalised Chronic Heart Failure Patients
An observational study of Education, Nursing, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Background: Nurses, the usual leaders in the follow-up of chronic cardiac patients, need to improve their training so that they are in the best position to empower these patients. From this approach, health coaching is presented as an innovative and valid alternative. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Nursing
- What is being tested?
- Training program
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 30 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinical nurses working in the cardiology ward during the time of the intervention evaluation were the target population from which the sample was taken.
Who may be able to join
- Nurses working in the cardiology ward.
- Nurses working full-time and part-time.
- Nurses with permanent and temporary contracts.
Who cannot join
- Nurses who were not working during the time of the study (sick or maternity leaves).
- Nurses with short contracts (<one year).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nursing Capacity Building in Health Coaching With Hospitalised Chronic Heart Failure Patients: An Intervention Study
Background: Nurses, the usual leaders in the follow-up of chronic cardiac patients, need to improve their training so that they are in the best position to empower these patients. From this approach, health coaching is presented as an innovative and valid alternative. Despite this, no studies have been found that implement and evaluate this type of program in the hospital setting.
Purpose: to evaluate the preliminary efficacy of this programme for the development of nursing capacity in health coaching with CHF (Chronic Heart Failure) inpatients.
Method: An exploratory pre-post quasi-experimental pilot study. Nineteen nurses, the total population of nurses working in the cardiology ward, were recruited in September 2020. All the nurses received a multi-component intervention based on health coaching. The strategies of this program consisted in five 16-hour sessions using case studies to find out whether nurses were able to empower chronic cardiac patients and debriefing and a 4-hour booster session seven months later. The I-CEpSE instrument was used to assess outcomes. The primary outcome was the difference in the median of knowledge, skills and attitudes pre and post intervention (between T0-T1, T2-T3 and T0-T3). Changes within nurses were analyzed using U Mann-Whitney test for independent samples.
Read the detailed description
Data collection:
Data collection was divided into four times: T0, T1, T2 and T3. T0 and T2 corresponded to preintervention data and T1 and T3 to postintervention data (T1 after the training and T3 one year later, after the whole intervention implementation).
At all four times, the I-CEpSE (competent health education practice, (in Spanish, 'Instrumento Competencia de Educación para la Salud del profesional de Enfermería'))instrument was collected as a means to measure self-reported nurses' knowledge, skills, and attitudes regarding competency-based health education. This questionnaire includes 58 items grouped into 3 domains: 1) Knowledge (items 1-23); 2) Skills (items 24-49); and 3) Attitudes (items 50-58). In turn, the skills domain is divided into two dimensions: personal/social skills (items 24-34) and educational skills (items 35-49). This is a validated instrument with good psychometric properties, internal consistency was high for each total scale (cognitive domain: Cronbach α = 0.95; psychomotor: Cronbach α = 0.95; attitudinal and affective: Cronbach α = 0.90) and for all factors (Cronbach α values ranged from 0.81-0.95).
Ethical considerations:
This study conformed to the principles set out in the Declaration of Helsinki and was approved by the centre's board and by the Research Ethics Committee (code 2019.066). Data custody complied with Organic Law 3/2018 on data protection (LOPDE). Informed consents were given to all participants. They were informed verbally and in writing about their free participation, the confidentiality and anonymity of the data and its use for scientific purposes. Nobody declined to participate or withdrew at any point of the study.
- Conditions
- Education, Nursing
- Being tested
- Training program
- Keywords
- Health coaching, Intervention, Chronic heart failure, Empowerment
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
A multi-component intervention based on health coaching. The strategies of this program consisted in five 16-hour sessions using case studies to find out whether nurses were able to empower chronic cardiac patients and debriefing and a 4-hour booster session seven months later.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Measurement tool: I-CEpSE instrument
Measured: T0 (2020 October)
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Measurement tool: I-CEpSE instrument
Measured: T1 (2020 November)
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Measurement tool: I-CEpSE instrument
Measured: T2 (2021 May first)
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Measurement tool: I-CEpSE instrument
Measured: T3 (2021 May last)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Oct 2020
- Primary completion28 May 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Education, NursingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300880
- Sponsor's protocol ID
- HCHCHF
- Status last verified
- Feb 2022
- First submitted
- 4 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paloma B, Olano-Lizarraga M, Rumeu-Casares C, Quesada A, Saracibar-Razquin M, Vazquez-Calatayud M. [Level of empowerment of hospitalized chronic heart failure patient]. An Sist Sanit Navar. 2021 Dec 27;44(3):351-360. doi: 10.23938/ASSN.0960. Spanish.
PubMed 34142990Vazquez-Calatayud M, Olano-Lizarraga M, Quesada-Melero AM, Rumeu-Casares C, Saracibar-Razquin M, Paloma-Mora B. Nursing capacity building in health coaching with hospitalised chronic heart failure patients: a quasi-experimental study. Contemp Nurse. 2023 Dec;59(6):443-461. doi: 10.1080/10376178.2023.2262612. Epub 2024 Jan 17.
PubMed 37751247
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Capacity Building in Health Coaching With Hospitalised Chronic Heart Failure Patients: An Intervention Study
- ClinicalTrials.gov ID
- NCT05300880
- Acronym / sponsor ID
- HCHCHF
- Conditions
- Education, Nursing
- Keywords
- Health coaching, Intervention, Chronic heart failure, Empowerment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Mar 2022 (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.
Background: Nurses, the usual leaders in the follow-up of chronic cardiac patients, need to improve their training so that they are in the best position to empower these patients. From this approach, health coaching is presented as an innovative and valid alternative. Despite this, no studies have been found that implement and evaluate this type of program in the hospital setting.
Purpose: to evaluate the preliminary efficacy of this programme for the development of nursing capacity in health coaching with CHF (Chronic Heart Failure) inpatients.
Method: An exploratory pre-post quasi-experimental pilot study. Nineteen nurses, the total population of nurses working in the cardiology ward, were recruited in September 2020. All the nurses received a multi-component intervention based on health coaching. The strategies of this program consisted in five 16-hour sessions using case studies to find out whether nurses were able to empower chronic cardiac patients and debriefing and a 4-hour booster session seven months later. The I-CEpSE instrument was used to assess outcomes. The primary outcome was the difference in the median of knowledge, skills and attitudes pre and post intervention (between T0-T1, T2-T3 and T0-T3). Changes within nurses were analyzed using U Mann-Whitney test for independent samples.
Detailed description
Data collection:
Data collection was divided into four times: T0, T1, T2 and T3. T0 and T2 corresponded to preintervention data and T1 and T3 to postintervention data (T1 after the training and T3 one year later, after the whole intervention implementation).
At all four times, the I-CEpSE (competent health education practice, (in Spanish, 'Instrumento Competencia de Educación para la Salud del profesional de Enfermería'))instrument was collected as a means to measure self-reported nurses' knowledge, skills, and attitudes regarding competency-based health education. This questionnaire includes 58 items grouped into 3 domains: 1) Knowledge (items 1-23); 2) Skills (items 24-49); and 3) Attitudes (items 50-58). In turn, the skills domain is divided into two dimensions: personal/social skills (items 24-34) and educational skills (items 35-49). This is a validated instrument with good psychometric properties, internal consistency was high for each total scale (cognitive domain: Cronbach α = 0.95; psychomotor: Cronbach α = 0.95; attitudinal and affective: Cronbach α = 0.90) and for all factors (Cronbach α values ranged from 0.81-0.95).
Ethical considerations:
This study conformed to the principles set out in the Declaration of Helsinki and was approved by the centre's board and by the Research Ethics Committee (code 2019.066). Data custody complied with Organic Law 3/2018 on data protection (LOPDE). Informed consents were given to all participants. They were informed verbally and in writing about their free participation, the confidentiality and anonymity of the data and its use for scientific purposes. Nobody declined to participate or withdrew at any point of the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical nurses working in the cardiology ward during the time of the intervention evaluation were the target population from which the sample was taken.
Key inclusion criteria (3 listed)
- Nurses working in the cardiology ward.
- Nurses working full-time and part-time.
- Nurses with permanent and temporary contracts.
Key exclusion criteria (2 listed)
- Nurses who were not working during the time of the study (sick or maternity leaves).
- Nurses with short contracts (<one year).
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 |
|---|---|---|
| Training programA multi-component intervention based on health coaching. The strategies of this program consisted in five 16-hour sessions using case studies to find out whether nurses were able to empower chronic cardiac patients and debriefing and a 4-hour booster session seven months later. | Other | – |
Primary outcome
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Time frame: T0 (2020 October)
Measurement tool: I-CEpSE instrument
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Time frame: T1 (2020 November)
Measurement tool: I-CEpSE instrument
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Time frame: T2 (2021 May first)
Measurement tool: I-CEpSE instrument
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58)
Time frame: T3 (2021 May last)
Measurement tool: I-CEpSE instrument
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 29 Mar 2022.
- Results publication: PubMed 34142990Paloma B, Olano-Lizarraga M, Rumeu-Casares C, Quesada A, Saracibar-Razquin M, Vazquez-Calatayud M. [Level of empowerment of hospitalized chronic heart failure patient]. An Sist Sanit Navar. 2021 Dec 27;44(3):351-360. doi: 10.23938/ASSN.0960. Spanish.
- Derived from this study: PubMed 37751247Vazquez-Calatayud M, Olano-Lizarraga M, Quesada-Melero AM, Rumeu-Casares C, Saracibar-Razquin M, Paloma-Mora B. Nursing capacity building in health coaching with hospitalised chronic heart failure patients: a quasi-experimental study. Contemp Nurse. 2023 Dec;59(6):443-461. doi: 10.1080/10376178.2023.2262612. Epub 2024 Jan 17.
- Level of empowerment of hospitalized chronic heart failure patient.Link provided by the sponsor.
Related trials for Education, Nursing
Not yet recruiting
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial
First Aid, Health Education in Schoolchildren
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Not yet recruiting
SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY
Simulation Training, Nursing Education
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Education, Nursing, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 3 inclusion and 2 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 29 Mar 2022. 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 Spain. 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?
Knowledge (items 1-23), Skills: personal/social skills (items 24-34) and educational skills (items 35-49) and Attitudes (items 50-58) (time frame: T0 (2020 October)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300880, which also lists 2 linked publications.
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 29 Mar 2022.