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Clinical Trials/NCT02398799
NCT02398799
Completed
Not Applicable

Supporting Dyads Affected by Heart Failure - A Randomised Controlled Study Evaluating a Psychoeducational Intervention

Linkoeping University0 sites155 target enrollmentJanuary 2005
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Linkoeping University
Enrollment
155
Primary Endpoint
Perceived control measure by Control Attitude Scale
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with chronic heart failure and their partners during a post-discharge period after acute deterioration of heart failure.

Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or a psycho-education intervention delivered in three modules through nurse-led face-to-face counseling, computer-based education and other written teaching materials to assist dyads develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24 months to assess perceived control, perceived health, depressive symptoms, self-care, knowledge, caregiver burden and health care utilization.

Detailed Description

Heart failure is a serious condition with a poor prognosis. It is the leading cause of hospitalization and readmissions for worsening heart failure remains high. Treatment aims to reduce symptoms and morbidity and to improve quality of life and survival. Counseling and education is an important part of treatment, but despite the fact that most patients receive education, many are not able to adequately engage in self-care activities. Non-adherence to self-care recommendations is high which may be a contributing factor for worsening heart failure and to the high number of readmissions. Having support of a partner is important for patients with heart failure. Supportive others have the potential to improve self-care outcomes and increase adherence to treatment. At the same time, it should be acknowledged that the disease can also affect the partners negatively. However, emotional reactions of burden and stress decrease when partner's experiences control over the heart disease. Despite the fact that heart failure has a number of negative consequences for patients and the partners, research addressing self-care barriers from a family perspective is rare, and until now contemporary care has remained patient focused. Previous studies have indicated the importance of partner support but have not found the appropriate methods for involving and encourage partners. Therefore, studies focusing on the heart failure patient-partner dyad are needed, but to date, most studies have only evaluated short term effects of intervention programs, while long term effects might be of equally importance. The aim of this randomized controlled study was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with chronic heart failure and their partners during a post-discharge period after acute deterioration of heart failure. Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care (n = 71) or a psycho-education intervention (n = 84) delivered in three modules through nurse-led face-to-face counseling, computer-based education and other written teaching materials to assist dyads develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24 months to assess perceived control, perceived health, depressive symptoms, self-care, knowledge, caregiver burden and health care utilization.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
December 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Anna Stroemberg

professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria were to be a dyad consisting of a patient diagnosed with heart failure based on the European Society of Cardiology guidelines,
  • New York Heart Association (NYHA) class II-IV,
  • with a partner living in the same household as the patient,
  • recently discharged from hospital (i.e. 2-3 weeks) following a heart failure acute exacerbation.

Exclusion Criteria

  • Exclusion criteria for the dyads were dementia, or other severe psychiatric illnesses,
  • drug abuse,
  • difficulties in understanding or reading the Swedish language,
  • undergoing cardiac surgery including cardiac transplant or
  • participating in other studies.

Outcomes

Primary Outcomes

Perceived control measure by Control Attitude Scale

Time Frame: 3 months

Perceived control in patients and partners

Secondary Outcomes

  • Quality of life measure by SF-36(3, 12 and 24 months)
  • Self care measured by European Self-care Behaviour Scale(3, 12 and 24 months)
  • Caregiverburden measured by Caregiverburden Scale(3, 12 and 24 months)

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