- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300880
Health Coaching With Hospitalised Chronic Heart Failure Patients
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nurses working in the cardiology ward.
- Nurses working full-time and part-time.
- Nurses with permanent and temporary contracts.
Exclusion Criteria:
- Nurses who were not working during the time of the study (sick or maternity leaves).
- Nurses with short contracts (<one year).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
Time Frame: T1 (2020 November)
|
Measurement tool: I-CEpSE instrument
|
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)
Time Frame: T2 (2021 May first)
|
Measurement tool: I-CEpSE instrument
|
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)
Time Frame: T3 (2021 May last)
|
Measurement tool: I-CEpSE instrument
|
T3 (2021 May last)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCHCHF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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