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CompletedNCT05716685Updated Feb 8, 2023

Health Coaching to Empowering Hospitalised Chronic Heart Failure Patients

An observational study in Education and Nursing, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
59
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Education
  • Nursing

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Keywords

  • Health coaching
  • Intervention
  • Chronic heart failure
  • Empowerment
03

In context

Empowerment

46 studies on the registry are indexed under Empowerment; 18 are open to participants now.

Browse Empowerment studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

chronic heart failure patients

Eligibility criteria

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.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
59 participants (actual)
Target follow-up
19 Months
Patient registry
Yes

Interventions

  • OtherHealth 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: T1, pre-intervention ( 2019 August - 2020 February)

  2. 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

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

07

Study locations

1 site
  • UCEC
    Pamplona, Navarre 31008, Spain
08

References and documents

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 34142990 ↗
  • 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. Spanish. PubMed 33275128 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2019 to primary completion in Mar 2022, 31 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2023
First posted
Feb 8, 2023
StartActual
Aug 9, 2019
Primary completionActual
Mar 28, 2022
CompletionActual
Jan 25, 2023
Last update
Feb 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05716685
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Aug 9, 2019
Primary completion
Mar 28, 2022
Completion
Jan 25, 2023
Last update
Feb 8, 2023

Study contacts

Beatriz Paloma, MD
principal investigator · Clinica Universidad de Navarra

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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