Clinical trial NCT06701916: SHARE Study: Social Chronic Heart Failure Person-centred cARE Intervention
Official title: Effect of a Person-centred Care Intervention on the Social Dimension of People With Chronic Heart Failure: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Person-centredness
RCT
Process evaluation
Health plan
Partnership
Person-centred care
Person-centered care
patient-centered care
Heart failure
social isolation
social support
social dimension
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: University of Navarra
name: Hospital of Navarra
name: University of Gothenburg Center for Person-Centred Care, GPCC
name: Hospital Donostia
name: Instituto de InvestigaciÃ³n Sanitaria de Navarra (IdiSNA)
First posted: 2024-11-22
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment An RCT: Heart failure patients who consent to participate and meet the inclusion criteria will be randomized. Randomization will be conducted by research nurses. Participants will be randomly assigned to either the control or intervention group with a 1:1 allocation, according to computer-generated randomization. The control group will receive usual care, while the intervention group will receive a person-centered care intervention for three months in addition to usual care.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effect of a PCC intervention on the ability to participate in social roles and activities in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on perceived self-efficacy in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
Secondary outcomes:
measure: Evaluate the effect of a PCC intervention on the perceived level of social isolation in individuals with CHF.
timeFrame: Time Frame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on self-care behaviors in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on the experience of living with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on the quality of life of individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on anxiety and depression levels in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
Other outcomes:
measure: Evaluate the effect of a PCC intervention on hospitalization rates in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on decompensation rates in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on the number of emergency department visits in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
measure: Evaluate the effect of a PCC intervention on all-cause mortality in individuals with CHF.
timeFrame: Baseline, 3, 6 months.
Locations:
city: Pamplona
country: Spain
facility: Universidad de Navarra, Facultad de Enfermería
state: Navarra
Study officials:
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