Official title: 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.

Read the 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.

Conditions: Heart Failure
Being tested: Intervention group., Usual care
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
Medical subject headings: Heart Failure, Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention group.Behavioural
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.
Usual careBehavioural
Usual care for the outpatient management of Chronic Heart Failure.

Study groups in NCT06701916
Study group	Role	What they receive
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. Receives: Behavioral: Intervention group.; Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
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.
Measured: Time Frame: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.
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.
Measured: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on self-care behaviors in individuals with CHF.
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.
Measured: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the experience of living with CHF.
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.
Measured: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on the quality of life of individuals with CHF.
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.
Measured: Baseline, 3, 6 months.
Evaluate the effect of a PCC intervention on anxiety and depression levels in individuals with CHF.
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.
Measured: Baseline, 3, 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202531 Aug 2027

First posted22 Nov 2024
Study start10 Jan 2025 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion31 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 374 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06701916
Sponsor's protocol ID: UNAV-SHARE
Acronym: SHARE
Status last verified: Nov 2024
First submitted: 19 Nov 2024
Last updated: 22 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32690519
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.
PubMed 38564982
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.
PubMed 26792391
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.
PubMed 25159126
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.
PubMed 31782661
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.
PubMed 30169539
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.
PubMed 21926072
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.
PubMed 33693738
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.
PubMed 35737922
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.
PubMed 34918403
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.
PubMed 34731695
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.
PubMed 31642086
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.
PubMed 27273246
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.
PubMed 34447992
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.
PubMed 31992061

Interested in taking part?

Maddi Olano, PhD in Nursing

+34 948 425600. ext. Ext. 606339

molizarraga@unav.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Person-centred Care Intervention on the Social Dimension of People With Chronic Heart Failure: A Randomised Controlled Trial
ClinicalTrials.gov ID: NCT06701916
Acronym / sponsor ID: SHARE / UNAV-SHARE
Conditions: Heart Failure
Keywords: Person-centredness, RCT, Process evaluation, Health plan, Partnership, Person-centred care, Person-centered care, patient-centered care
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 374 participants (estimated)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Collaborators: University of Navarra, Hospital of Navarra, Göteborg University, Hospital Donostia, Fundación Instituto de Investigación Sanitaria de Navarra
Study start: 10 Jan 2025 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Aug 2027 (estimated)
First posted: 22 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
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	Behavioral: Intervention group., Behavioral: Usual careThe Person-Centred Care intervention will be delivered for 3 months on top of usual care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Intervention group.
Usual careUsual care for the outpatient management of Chronic Heart Failure.	Behavioural	Intervention group.

Primary outcome

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.
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.

6 secondary outcomes

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.
Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.
Time frame: 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.
Evaluate the effect of a PCC intervention on the experience of living with CHF.
Time frame: 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.
Evaluate the effect of a PCC intervention on anxiety and depression levels in individuals with CHF.
Time frame: Baseline, 3, 6 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Background: PubMed 32690519Ali 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.
Background: PubMed 38564982Skivington 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.
Background: PubMed 26792391Markgren 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.
Background: PubMed 25159126Brannstrom 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.
Background: PubMed 31782661Wallstrom 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.
Background: PubMed 30169539Fors 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.
Background: PubMed 21926072Ekman 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.
Background: PubMed 33693738Ekman 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.
Background: PubMed 35737922Olano-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.
Background: PubMed 34918403Olano-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.
Background: PubMed 34731695Olano-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.
Background: PubMed 31642086Olano-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.
Individual participant dataSharing planned: No

Related trials for Heart Failure

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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Heart Failure, Diastolic, Diastolic Heart Failure
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Maddi Olano, PhD in Nursing contact

+34 948 425600. ext. Ext. 606339

molizarraga@unav.es

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group. in people with Heart Failure, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maddi Olano, PhD in Nursing (+34 948 425600. ext. Ext. 606339, molizarraga@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06701916, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.