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Clinical Trials/NCT05716685
NCT05716685
Completed
Not Applicable

Evaluation of Health Coaching to Empowering Hospitalised Chronic Heart Failure Patients

Clinica Universidad de Navarra, Universidad de Navarra1 site in 1 country59 target enrollmentAugust 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Education
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Enrollment
59
Locations
1
Primary Endpoint
Attitude and sense of control (21 items); Shared and informed decision-making (13 items); and Information seeking and peer sharing (13 items)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 9, 2019
End Date
January 25, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥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.

Outcomes

Primary Outcomes

Attitude and sense of control (21 items); Shared and informed decision-making (13 items); and Information seeking and peer sharing (13 items)

Time Frame: T2, after completion of the intervention (2021 January - 2022 March) .

Measurement tool: The Patient empowerment in long-term conditions Questionnaire

Study Sites (1)

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