Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure

NCT01304381 | Completed DMC

• 1 other identifier: HOPE001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with severe heart failure have as many symptoms as many patients with cancer but yet do not have equal access to supportive and palliative care. They have an unpredictable course of illness, which makes difficult to judge when the palliative stage has been reached. The Heart failure and Palliative care Programme is a three-year project in Sweden financed by the Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop, implement and evaluate a model that integrates cardiac care and palliative advanced home care for patients with severe chronic heart failure. The primary aim is to study the effects on patients' symptom burden, quality of life and activities of daily living. A randomized controlled clinical study is planned. Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the European Society of Cardiology and with NYHA III-IV symptoms and at least one of following criteria will be included;

1. 1.At least one episode of worsening heart failure that resolved with injection / infusion of diuretics or the addition of other heart failure treatment in the last 6 months and regarded optimally treated according to the responsible physician.
2. 2.Need for infusions-treatment.
3. 3.Chronic poor quality of life (VAS \< 50)
4. 4.Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
5. 5.less than one year life expectancy The participants will be randomized to intervention or control group. The intervention consist of a multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers, in a shared structured person-centred and identity-promoting care at home during six months. Usual care is performed for the control group.

Conditions

Chronic Heart Failure

Keywords

Heart failure; Palliative care; Integrated care

Outcome Measures

Primary Outcomes (1)

• changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks

  baseline and after 4, 16 and 24 weeks

Secondary Outcomes (1)

• changes from baseline value of quality of life scores on the EQ-5D and activities in daily life (ADL) after intervention of 4, 12 and 24 weeks

  baseline, after 4,16 and 24 weeks

Study Arms (2)

Integrated care

EXPERIMENTAL

Multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers in a shared structured person-centred and identity-promoting homecare

Other: Integrated care

control

NO INTERVENTION

Usual care is performed for the control group

Interventions

Integrated care OTHER

Intervention Multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers, in a shared structured person-centred and identity-promoting care during 6 months

Integrated care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Ineligible are patients:
• who do not want to participate in the study;
• with severe communication problems;
• with severe dementia;
• with other serious disease in which heart failure is of secondary importance;
• with other life-threatening illness as the primary diagnosis with expected short survival;
• when the Primary Care Center which is responsible for patient care is geographically located from more than 30 km radius outside the hospital; and
• participating in another clinical trial. -

Sponsors & Collaborators

• Umeå University: lead
• Swedish Association of Local Authorities and Regions: collaborator

Study Sites (1)

Skellefteå hospital

Skellefteå, Västerbotten County, 93186, Sweden

Location

Related Publications (6)

• Brännström M, Brulin C, Norberg A, Boman K, Strandberg G (2005). Being a palliative nurse for persons with severe congestive heart failure in advanced homecare. European Journal of Cardiovascular Nursing, 2005;4 (4):314-323. Brännström M, Ekman I, Norberg A, Boman K, Strandberg G. Living with severe chronic heart failure in palliative advanced home care. European Journal of Cardiovascular Nursing, 2006;5(4):295-302. Brännström M, Ekman I, Boman K, Strandberg G. Being a close relative of a person with severe chronic heart failure in palliative advanced home care - a comfort but also a strain. Scandinavian Journal of Caring Sciences, 2007;21(3):338-344 . Brännström M, Ekman I, Boman K, Strandberg G. Narratives of a man with severe chronic heart failure and his wife in palliative advanced home care over a 4.5-year period. Contemporary Nurse, 2007;27(2):10-22. Brännström M, Björck M, Strandberg G, Wanhainen A. Patients' experiences of being informed about having an abdominal aortic aneurysm - A follow-up case study five years after screening. Journal of Vascular Nursing, 2009;27(3):70-4. Lundman B, Brännström M, Hägglund L, Strandberg G. Fatigue in elderly with chronic heart failure: an under-recognized symptom. Aging Health, 2009;5,(5):619-624. Kristofferzon ML, Johansson I, Brännström M, Arenhall E, Baigi A Brunt D, Fridlund B, Nilsson U, Persson S, Rask M, Wieslander I, Ivarsson B and the SAMMI-study group. Evaluation of a Swedish version of the Watts Sexual Function Questionnaire (WSFQ) in persons with heart disease: A pilot study. European Journal of Cardiovascular Nursing 2010;9(3):168-174 Brännström M, Forssell A, Pettersson B. Physicians' experiences of palliative care for heart failure patients. European Journal of Cardiovascular Nursing, 2011;10(1):64-69.

  BACKGROUND

• Talabani N, Angerud KH, Boman K, Brannstrom M. Patients' experiences of person-centred integrated heart failure care and palliative care at home: an interview study. BMJ Support Palliat Care. 2020 Mar;10(1):e9. doi: 10.1136/bmjspcare-2016-001226. Epub 2017 Jul 7.

  PMID: 28689185 DERIVED

• 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 DERIVED

• Sahlen KG, Boman K, Brannstrom M. A cost-effectiveness study of person-centered integrated heart failure and palliative home care: Based on a randomized controlled trial. Palliat Med. 2016 Mar;30(3):296-302. doi: 10.1177/0269216315618544. Epub 2015 Nov 24.

  PMID: 26603186 DERIVED

• 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 DERIVED

• Brannstrom M, Boman K. A new model for integrated heart failure and palliative advanced homecare--rationale and design of a prospective randomized study. Eur J Cardiovasc Nurs. 2013 Jun;12(3):269-75. doi: 10.1177/1474515112445430. Epub 2012 May 28.

  PMID: 22645405 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

SE (1)