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Completed

NCT Number: NCT02398799

Supporting Dyads Affected by Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychoeducational Support

Behavioral

The intervention was based on a conceptual model from Stuifbergen. The model has sprung from Pender's model of health promotion and Bandura's self-efficacy theory. Cognitive-behavioral strategies were chosen to assist dyads in recognizing and modifying factors that contribute to physical and emotional distress by changing thoughts and behaviors and assisting dyads in solving problems related to implementing strategies for self-care.

Shared care is a dyadic process based on the assumption that each participant affects and is affected by the other. Shared goals and a shared commitment provide the essential building blocks of the dyad relationship. The dyad structure presents an opportunity for healthcare professionals to integrate a collaborative patient-partner centered effort.

Primary outcomes

  1. Perceived control measure by Control Attitude Scale

    Time frame: 3 months

    Perceived control in patients and partners

Secondary outcomes

  1. Quality of life measure by SF-36

    Time frame: 3, 12 and 24 months

    Quality of life in patients and partners

  2. Self care measured by European Self-care Behaviour Scale

    Time frame: 3, 12 and 24 months

    Self care in patients

  3. Caregiverburden measured by Caregiverburden Scale

    Time frame: 3, 12 and 24 months

    Caregiverburden in partners

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Mar 26, 2015
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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