SHARE Study: Social Chronic Heart Failure Person-centred cARE Intervention (SHARE)

November 19, 2024 updated by: Maddi Olano, Clinica Universidad de Navarra, Universidad de Navarra

Effect of a Person-centred Care Intervention on the Social Dimension of People With Chronic Heart Failure: A Randomised Controlled Trial

People with Chronic Heart Failure (CHF) live with a complex situation that significantly affects their quality of life and well-being. Among the consequences of CHF that have the greatest impact on individuals is the effect it has on their social dimension. The symptomatic burden they experience, along with the influence of social determinants, social support, and psychosocial factors, results in disability and limitations in maintaining an adequate social life and roles, participating in social events, and having relationships beyond their closest family circle. Various international health organizations have emphasized the need to move towards Person-Centered Care (PCC). Adopting this approach involves shifting from a model in which the patient is a passive subject of a medical intervention to one in which the patient takes an active role in their care and decision-making process. The aim of this study is to assess the effectiveness of a PCC intervention on the social dimension of people with CHF. The study will be conducted at the Outpatient Heart Failure Units of Donostia University Hospital, the University Hospital of Navarra, and the University of Navarra Clinic in Pamplona. A randomized controlled, open-label, parallel-group, multicenter clinical trial will be carried out, based on the Medical Research Council framework. This will evaluate the effect of a three-month intervention consisting of in-person and telephone support centered on the person, in addition to usual care, compared to usual care alone, in a sample of 374 individuals. The intervention will be implemented by a multidisciplinary team comprising nurses, doctors, social workers, and psychologists from each hospital. Through this intervention, a patient narrative will be obtained regarding their goals, desires, capabilities, and resources related to their health situation. A health plan will be jointly created that will reflect short- and long-term goals, identify the resources available to the person and in their immediate environment, and outline how they want and expect to receive support from healthcare professionals. To assess its impact, the intervention's effect on the ability to participate in social roles and activities, perceived level of social isolation, and perception of social support will be measured. Additionally, the effect on self-efficacy perception, level of self-care and treatment adherence, anxiety and depression, and overall health experience with the disease will be evaluated, as well as rates of hospitalization, disease decompensation, emergency visits, and death.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background According to the WHO, heart disease has been the leading cause of mortality worldwide for the past 20 years. Specifically, people with Chronic Heart Failure (CHF) have become a priority group in healthcare systems. The prevalence of CHF in the adult population of industrialized countries reaches 3% and is expected to increase due to its chronic and progressive nature, driven by advances in healthcare. Currently, women make up 50.3% of the global prevalence, and it has been found that more than 10% of people over 70 suffer from it.

Several studies have shown that people with CHF live in a complex situation that significantly impacts their quality of life and overall well-being. This is because, on one hand, they must cope with complex treatment regimens, strict self-care behaviors, and lifestyle changes that affect their daily lives. On the other hand, they experience situations that lead to profound changes in all their personal dimensions, including physical restrictions, emotional and spiritual needs, and the impact on family and social roles. Despite this, the healthcare provided to these patients, as is the case with other chronic conditions, primarily focuses on disease management and the prevention of complications, while other aspects related to the experience of living with CHF are not being addressed.

Healthcare systems need to reorganize to provide high-quality care without increasing costs to an aging population with a high prevalence of chronic and long-term conditions. Several leading international health organizations, including the World Health Organization and the National Academy of Medicine, have emphasized the need to move toward increasingly person-centered healthcare systems. When healthcare is provided within the framework of Person-Centered Care (PCC), personal experiences, life stories, family, environment, and goals and desires are considered when planning health-related aspects. Each individual's subjectivity must be regarded as how they integrate into their environment and what their strengths and weaknesses, future plans, and rights are.

The SHARE study is expected to improve several key outcome indicators that enhance individuals' life experiences by combining current healthcare with the PCC approach. By reducing care demand, it will also contribute to the sustainability of the healthcare system.

Design This is an open-label, multicenter, randomized controlled clinical trial with parallel groups. It will be conducted as a superiority trial, where treatment comparisons will be made using "intention-to-treat" analysis. The study is based on the methodological framework of the Medical Research Council (MRC), which guides the development and evaluation of complex interventions. This research mainly focuses on studying effectiveness, i.e., to what extent the intervention achieves the intended outcomes in a real-world setting. The effect of a PCC intervention, in addition to the usual care received by individuals with CHF (intervention group), will be compared to usual care alone (control group).

Study setting / Context Outpatient Heart Failure Units at the OSI Donostialdea, the University Hospital of Navarra, and the University of Navarra Clinic in Pamplona.

Participants and recruitment procedure Participants will be recruited based on patient records from the CHF units at each hospital. The nursing professionals responsible for monitoring these patients, who will also be part of the research team, will review their weekly schedules and, using the described selection criteria, call potential participants a few days before their appointment to inform them about the possibility of participating in the study. On the day of the in-person consultation, the nurses will verbally explain the purpose of the study to the patients again and provide them with an information sheet for review. If they agree to participate, informed consent will be provided, and participants will be randomly assigned to the control or intervention group.

Study population The sample will consist of individuals with CHF who are being monitored for their condition at the hospitals mentioned above and meet the selection criteria.

Control group/Usual care These patients will not receive the intervention. Based on the European Society of Cardiology guidelines for managing these patients, they will receive the usual care for outpatient follow-up of their Chronic Heart Failure.

Intervention group In addition to standard care, patients in this group will receive the person-centered care intervention. They will have an initial in-person consultation (T0) with the nurse from the Heart Failure Unit. In this first session, the intervention will involve establishing a collaborative nurse-patient/family partnership, obtaining the patient's narrative, and designing and documenting a health plan. Through various communication skills, such as using open-ended questions, reflections, or summaries, the nurse will encourage the patient to share a narrative about their daily personal experiences and how CHF affects them, including the types of challenges they face and the resources available to them. During this dialogue, the nurse will take notes on the most relevant aspects of the narrative and identify the patient's health-related goals, capabilities, potential, personal/environmental resources, and needs. The patient (sometimes with their family) and the nurse will co-create a care plan collaboratively.

Additionally, the patient will be informed about scheduling a monthly phone appointment over the next three months with the same nurse to continue the plan and update the information related to the five elements recorded in the previous consultation, adapting them to new circumstances. The updated and agreed-upon plan will be sent to the patient's home by email or regular mail. Finally, the third-month consultation (T1) will serve to evaluate the last month's progress, plan longer-term goals with the patient, guide them in achieving these goals, and conclude the intervention.

Study Type

Interventional

Enrollment (Estimated)

374

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maddi Olano, PhD in Nursing
  • Phone Number: Ext. 606339 +34 948 425600.
  • Email: molizarraga@unav.es

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Universidad de Navarra, Facultad de Enfermería

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individuals over 18 years old;
  2. Functional class II-IV according to the NYHA;
  3. Adequate cognitive status and health condition that allows participation;
  4. Adequate spoken and written Spanish proficiency;
  5. Active phone line; and
  6. Voluntary signature of informed consent.

Exclusion Criteria:

  1. Having a severe concurrent illness;
  2. Life expectancy of less than 1 year;
  3. Receiving palliative care;
  4. Severe hearing impairment; and
  5. Known alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual Care. Participants allocated to the control group will not receive any additional intervention. They will receive standard care for the outpatient management of their Heart Failure, based on the recommendations of the European Society of Cardiology guidelines for the follow-up of heart failure patients.
Experimental: Intervention group.
The Person-Centred Care intervention will be delivered for 3 months on top of usual care.
Behavioral: Intervention group.
The intervention will be carried out by a multidisciplinary team composed of nurses, doctors, social workers, and psychologists from each hospital. Through this intervention, a narrative from the patients will be obtained regarding their goals, desires, capabilities, and resources related to their health situation. A health plan will be jointly created, reflecting both short- and long-term objectives, identifying the resources available to the person and within their immediate environment, and outlining how they want and expect to receive support from healthcare professionals.
Behavioral: Usual care
Usual care for the outpatient management of Chronic Heart Failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of a PCC intervention on the ability to participate in social roles and activities in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Neuro-QOL Item Bank v1.0 - Ability to Participate in Social Roles and Activities - Short Form A. (58). It consists of 7 items. Although originally designed for administration to individuals with chronic neurological conditions, this tool has been shown to be valid for use in other chronic conditions. It assesses the degree of participation in usual social roles, activities, and responsibilities, including work, family, friends, and leisure.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on perceived self-efficacy in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
General Self-Efficacy Scale (GSE) (60). This scale consists of 10 items and assesses the strength of an individual's belief in their own ability to respond to new or challenging situations and to overcome obstacles and setbacks.
Baseline, 3, 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of a PCC intervention on the perceived level of social isolation in individuals with CHF.
Time Frame: Time Frame: Baseline, 3, 6 months.
Revised UCLA Loneliness Scale (R-UCLA) (59). For this study, only the domain measuring social isolation, which contains 10 items, will be administered. This scale is designed to measure subjective feelings of loneliness as well as feelings of social isolation.
Time Frame: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
modified Medical Outcomes Study Social Support Survey (mMOS-SS) . This scale consist of items and is the abbreviated version of the MOS-SS scale designed to assess the perception of social support in people with chronic conditions. This version contains two subscales covering two domains, social/emotional and instrumental support.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on self-care behaviors in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
European Heart Failure Self-care Behaviour Scale (EHFScB-9) (63). This scale consists of 9 items and addresses aspects related to patient self-care behaviors, such as daily weight monitoring, fluid restriction, medication adherence, exercise, and contacting a healthcare professional.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the experience of living with CHF.
Time Frame: Baseline, 3, 6 months.
UNAV-Experience of Living with Chronic Heart Failure Scale (UNAV-CHF Experience Scale) (Olano-Lizarraga et al., in publication phase): This scale consists of 30 items and was designed to understand the experience of individuals living with CHF. It evaluates five dimensions: profound personal change, acceptance of the illness, perception of normality, hope, and perception of negatively impacting the family.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the quality of life of individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Kansas City Cardiomyopathy Questionnaire (KCCQ): This scale consists of 23 items and assesses health-related quality of life in individuals with CHF. It evaluates seven domains: physical limitation; symptoms, considering changes over time, frequency, and severity; self-efficacy and knowledge; quality of life; and social interference.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on anxiety and depression levels in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Hospital Anxiety and Depression Scale (HADS): This scale consists of 14 items, with 7 items in the anxiety subscale and 7 in the depression subscale. It was developed to indicate the possible presence of anxiety and depression in non-psychiatric outpatient patients.
Baseline, 3, 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of a PCC intervention on hospitalization rates in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Hospitalizations: The rate of unplanned hospitalizations related to CHF during the intervention and follow-up; data obtained from the medical record.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on decompensation rates in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Decompensations: The rate of symptomatic CHF decompensations during the intervention and follow-up; data obtained from the medical record.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the number of emergency department visits in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Unscheduled visits: The number of unscheduled emergency department visits related to CHF; data obtained from the medical record.
Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on all-cause mortality in individuals with CHF.
Time Frame: Baseline, 3, 6 months.
Death: Death from any cause; data obtained from the medical record.
Baseline, 3, 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Hospital Donostia
University of Navarra
Hospital Universitario de Navarra
University of Gothenburg Center for Person-Centred Care, GPCC
Instituto de Investigación Sanitaria de Navarra (IdiSNA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNAV-SHARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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