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

Summary

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.

Conditions

• Heart Failure

Interventions

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.

Sponsors & Collaborators

• University of Navarra

  collaborator OTHER

• Hospital of Navarra

  collaborator OTHER

• University of Gothenburg Center for Person-Centred Care, GPCC

  collaborator UNKNOWN

• Hospital Donostia

  collaborator OTHER

• Instituto de Investigación Sanitaria de Navarra (IdiSNA)

  collaborator UNKNOWN

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-10

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• Spain

Study Locations