Supporting Dyads Affected by Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398799
• Other study ID #: Dnr 03-568
• Status: Completed
• Phase: N/A
• First received: March 8, 2015
• Last updated: March 24, 2015
• Start date: January 2005
• Est. completion date: December 2010

Study information

• Verified date: March 2015
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Psychoeducational support
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived control measure by Control Attitude Scale	Perceived control in patients and partners	3 months	No
Secondary	Quality of life measure by SF-36	Quality of life in patients and partners	3, 12 and 24 months	No
Secondary	Self care measured by European Self-care Behaviour Scale	Self care in patients	3, 12 and 24 months	No
Secondary	Caregiverburden measured by Caregiverburden Scale	Caregiverburden in partners	3, 12 and 24 months	No