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

NCT06701916 | Not Yet Recruiting

• 1 other identifier: UNAV-SHARE
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Evaluate the effect of a PCC intervention on the ability to participate in social roles and activities in individuals with CHF.

  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.

  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 Outcomes (6)

• Evaluate the effect of a PCC intervention on the perceived level of social isolation in individuals with CHF.

  Time Frame: Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.

  Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on self-care behaviors in individuals with CHF.

  Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on the experience of living with CHF.

  Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on the quality of life of individuals with CHF.

  Baseline, 3, 6 months.

Other Outcomes (4)

• Evaluate the effect of a PCC intervention on hospitalization rates in individuals with CHF.

  Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on decompensation rates in individuals with CHF.

  Baseline, 3, 6 months.

• Evaluate the effect of a PCC intervention on the number of emergency department visits in individuals with CHF.

  Baseline, 3, 6 months.

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group.

EXPERIMENTAL

The Person-Centred Care intervention will be delivered for 3 months on top of usual care.

Behavioral: Intervention group.; Behavioral: Usual care

Interventions

Intervention group. BEHAVIORAL

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.

Intervention group.

Usual care BEHAVIORAL

Usual care for the outpatient management of Chronic Heart Failure.

Intervention group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Navarra: collaborator
• Hospital of Navarra: collaborator
• University of Gothenburg Center for Person-Centred Care, GPCC: collaborator
• Hospital Donostia: collaborator
• Instituto de Investigación Sanitaria de Navarra (IdiSNA): collaborator

Study Sites (1)

Universidad de Navarra, Facultad de Enfermería

Pamplona, Navarre, 31008, Spain

Location

Related Publications (16)

• Ali L, Wallstrom S, Barenfeld E, Fors A, Fredholm E, Gyllensten H, Swedberg K, Ekman I. Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e036356. doi: 10.1136/bmjopen-2019-036356.

  PMID: 32690519 BACKGROUND

• Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.

  PMID: 38564982 BACKGROUND

• Markgren R, Brannstrom M, Lundgren C, Boman K. Impacts of person-centred integrated chronic heart failure and palliative home care on pharmacological heart failure treatment: a substudy of a randomised trial. BMJ Support Palliat Care. 2019 Mar;9(1):e10. doi: 10.1136/bmjspcare-2015-000894. Epub 2016 Jan 20.

  PMID: 26792391 BACKGROUND

• Brannstrom M, Boman K. Effects of person-centred and integrated chronic heart failure and palliative home care. PREFER: a randomized controlled study. Eur J Heart Fail. 2014 Oct;16(10):1142-51. doi: 10.1002/ejhf.151. Epub 2014 Aug 27.

  PMID: 25159126 BACKGROUND

• Wallstrom S, Ali L, Ekman I, Swedberg K, Fors A. Effects of a person-centred telephone support on fatigue in people with chronic heart failure: Subgroup analysis of a randomised controlled trial. Eur J Cardiovasc Nurs. 2020 Jun;19(5):393-400. doi: 10.1177/1474515119891599. Epub 2019 Nov 29.

  PMID: 31782661 BACKGROUND

• Fors A, Blanck E, Ali L, Ekberg-Jansson A, Fu M, Lindstrom Kjellberg I, Makitalo A, Swedberg K, Taft C, Ekman I. Effects of a person-centred telephone-support in patients with chronic obstructive pulmonary disease and/or chronic heart failure - A randomized controlled trial. PLoS One. 2018 Aug 31;13(8):e0203031. doi: 10.1371/journal.pone.0203031. eCollection 2018.

  PMID: 30169539 BACKGROUND

• Ekman I, Wolf A, Olsson LE, Taft C, Dudas K, Schaufelberger M, Swedberg K. Effects of person-centred care in patients with chronic heart failure: the PCC-HF study. Eur Heart J. 2012 May;33(9):1112-9. doi: 10.1093/eurheartj/ehr306. Epub 2011 Sep 15.

  PMID: 21926072 BACKGROUND

• Ekman I, Ebrahimi Z, Olaya Contreras P. Person-centred care: looking back, looking forward. Eur J Cardiovasc Nurs. 2021 Apr 13;20(2):93-95. doi: 10.1093/eurjcn/zvaa025.

  PMID: 33693738 BACKGROUND

• Olano-Lizarraga M, Wallstrom S, Martin-Martin J, Wolf A. Interventions on the social dimension of people with chronic heart failure: a systematic review of randomized controlled trials. Eur J Cardiovasc Nurs. 2023 Mar 1;22(2):113-125. doi: 10.1093/eurjcn/zvac051.

  PMID: 35737922 BACKGROUND

• Olano-Lizarraga M, Wallstrom S, Martin-Martin J, Wolf A. Causes, experiences and consequences of the impact of chronic heart failure on the person s social dimension: A scoping review. Health Soc Care Community. 2022 Jul;30(4):e842-e858. doi: 10.1111/hsc.13680. Epub 2021 Dec 16.

  PMID: 34918403 BACKGROUND

• Olano-Lizarraga M, Martin-Martin J, Perez-Diez Del Corral M, Saracibar-Razquin M. Experiencing the possibility of near death on a daily basis: A phenomenological study of patients with chronic heart failure. Heart Lung. 2022 Jan-Feb;51:32-39. doi: 10.1016/j.hrtlng.2021.08.006. Epub 2021 Oct 29.

  PMID: 34731695 BACKGROUND

• Olano-Lizarraga M, Zaragoza-Salcedo A, Martin-Martin J, Saracibar-Razquin M. Redefining a 'new normality': A hermeneutic phenomenological study of the experiences of patients with chronic heart failure. J Adv Nurs. 2020 Jan;76(1):275-286. doi: 10.1111/jan.14237. Epub 2019 Nov 4.

  PMID: 31642086 BACKGROUND

• Olano-Lizarraga M, Oroviogoicoechea C, Errasti-Ibarrondo B, Saracibar-Razquin M. The personal experience of living with chronic heart failure: a qualitative meta-synthesis of the literature. J Clin Nurs. 2016 Sep;25(17-18):2413-29. doi: 10.1111/jocn.13285. Epub 2016 Jun 6.

  PMID: 27273246 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.

  PMID: 31992061 BACKGROUND

• Ekman I, Swedberg K, Taft C, Lindseth A, Norberg A, Brink E, Carlsson J, Dahlin-Ivanoff S, Johansson IL, Kjellgren K, Liden E, Ohlen J, Olsson LE, Rosen H, Rydmark M, Sunnerhagen KS. Person-centered care--ready for prime time. Eur J Cardiovasc Nurs. 2011 Dec;10(4):248-51. doi: 10.1016/j.ejcnurse.2011.06.008. Epub 2011 Jul 20.

  PMID: 21764386 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Social Isolation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Central Study Contacts

Maddi Olano, PhD in Nursing

CONTACT

+34 948 425600.; molizarraga@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the intervention means that neither participants nor the health care professionals in the SHARE intervention can be blinded to allocation in the RCT.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)