Health Coaching to Empowering Hospitalised Chronic Heart Failure Patients

Education Clinical Trial

Official title:

Evaluation of Health Coaching to Empowering Hospitalised Chronic Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716685
• Other study ID #: HCEP
• Status: Completed
• Start date: August 9, 2019
• Est. completion date: January 25, 2023

Study information

• Verified date: January 2023
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Aims: To evaluate the preliminary efficacy of Health Coaching in empowering hospitalised chronic heart failure patients.

Methods: pre-post quasi-experimental pilot study was carried out with 59 patients, allocated into the pre-intervention group (N=29) and post-intervention group (N=30) in a cardiology ward of a hospital. The intervention consisted of the knowledge traslation acquired on health coaching by the nurses of the cardiology unit to their care activity with CHF patients. The Patient empowerment in long-term conditions Questionnaire was used to measure heart failure patients: Attitude and sense of control; Shared and informed decision-making; and Information seeking and peer sharing, on two occasions: T1, pre-intervention, and T2, after completion of the intervention.

Description:

Data collection:

Data collection was carried out by two members of the research team, who were not directly involved in the care of the patients, at two points in time: T1, pre-intervention, and T2, post-intervention. Two questionnaires were used for data collection:

1. Patient empowerment questionnaire for patients with chronic illness (Garcimartin et al. 2019): validated instrument in Spain with good psychometric properties, excellent Cronbach's alpha (>0.9) and moderate interclass correlation coefficient (0.47). It consists of 47 items and 3 dimensions: 1) Positive attitude and sense of control (21 items); 2) Shared and informed decision-making (13 items); and 3) Information seeking and sharing among peers (13 items). Response options for each item are scored on a 5-point Likert-type scale (1 strongly disagree and 5 strongly agree). The overall score for each patient ranges from 47 (worst empowerment) to 235 (best empowerment).

2. Questionnaire to collect sociodemographic and clinical variables: sex, age, educational level, marital status, employment status, hospital stay, Charlson index, 10-year survival, functional class (I-IV; according to NYHA), time of diagnosis and admissions in recent months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 25, 2023
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1) =18 years old; (2) at any stage of their disease (I-IV), according to the New York Heart Association Functional Class (NYHA) classification; (3) who had been admitted for more than 3 days; (4) whose level of consciousness was normal and whose state of health allowed them to complete the questionnaire; (5) who spoke and understood Spanish and; (6) who signed the informed consent form.

Exclusion Criteria: Patients with cognitive impairment or unable to answer the questionnaire.

Related Conditions & MeSH terms

• Education
• Heart Failure
• Nursing

Intervention

Other:
• Health coaching
The intervention consisted of transferring the knowledge acquired on health coaching by the nurses of the cardiology unit to their care activity with CHF patients. To this end, all the nurses in the cardiology unit received two training packages: 1) five theoretical and practical sessions on health coaching competencies, emotional intelligence, communication and support for CHF patients in the hospital setting; and 2) training sessions 7 months after the first training package to reinforce the theoretical and practical knowledge acquired in health coaching. During this period, debriefing was carried out to provide feedback on the health coaching process with patients.

Locations

Country	Name	City	State
Spain	UCEC	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

Perez Paloma P, Gonzalez Urmeneta I, Roda-Casado C, Vazquez-Calatayud M. [A systematic review of interventions to empower patient with chronic heart failure in hospital environment]. An Sist Sanit Navar. 2020 Dec 22;43(3):393-403. doi: 10.23938/ASSN.0925. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitude and sense of control (21 items); Shared and informed decision-making (13 items); and Information seeking and peer sharing (13 items)	Measurement tool: The Patient empowerment in long-term conditions Questionnaire	T1, pre-intervention ( 2019 August - 2020 February)
Primary	Attitude and sense of control (21 items); Shared and informed decision-making (13 items); and Information seeking and peer sharing (13 items)	Measurement tool: The Patient empowerment in long-term conditions Questionnaire	T2, after completion of the intervention (2021 January - 2022 March) .