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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Integrated care
Integrated care
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring Heart failure, Palliative care, Integrated care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients 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;

  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. Need for infusions-treatment.
  3. Chronic poor quality of life (VAS < 50)
  4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
  5. less than one year life expectancy.

Exclusion Criteria:

Ineligible are patients:

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

Sites / Locations

  • Skellefteå hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated care

control

Arm Description

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

Usual care is performed for the control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2011
Last Updated
June 16, 2013
Sponsor
Umeå University
Collaborators
Swedish Association of Local Authorities and Regions
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1. Study Identification

Unique Protocol Identification Number
NCT01304381
Brief Title
Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure
Official Title
Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Swedish Association of Local Authorities and Regions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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; 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. Need for infusions-treatment. Chronic poor quality of life (VAS < 50) Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Heart failure, Palliative care, Integrated care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated care
Arm Type
Experimental
Arm Description
Multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers in a shared structured person-centred and identity-promoting homecare
Arm Title
control
Arm Type
No Intervention
Arm Description
Usual care is performed for the control group
Intervention Type
Other
Intervention Name(s)
Integrated care
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Integrated care
Intervention Description
One group with 31 participants is offered a multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers in a shared structured person-centred care at home. Assessment of need, length of visits and phone calls are planned to be adapted for each patient. After 6 months (+ - two weeks) the patients will be transferred to usual care provider following an established individual care plan.
Primary Outcome Measure Information:
Title
changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks
Time Frame
baseline and after 4, 16 and 24 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
baseline, after 4,16 and 24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients 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; 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. Need for infusions-treatment. Chronic poor quality of life (VAS < 50) Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months) less than one year life expectancy. Exclusion Criteria: 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. -
Facility Information:
Facility Name
Skellefteå hospital
City
Skellefteå
State/Province
Västerbotten
ZIP/Postal Code
93186
Country
Sweden

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
28689185
Citation
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.
Results Reference
derived
PubMed Identifier
26792391
Citation
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.
Results Reference
derived
PubMed Identifier
26603186
Citation
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.
Results Reference
derived
PubMed Identifier
25159126
Citation
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.
Results Reference
derived
PubMed Identifier
22645405
Citation
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.
Results Reference
derived

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

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