Supporting Dyads Affected by Heart Failure

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Psychoeducational support

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control; The dyads in the control group received care as usual including traditional care in hospital and outpatient education and support. The care is mainly focused on the patient's needs. The partner is not systematically involved in the follow-up focusing on education and psychosocial support.
EXPERIMENTAL: Psycho edcuactional support; The intervention psychoeducational support to the patient-partner dyads was delivered in 3 sessions through nurse-led face-to-face counseling, a computer-based CD-ROM program and other written teaching materials. All sessions lasted at least 60 minutes and were conducted in the dyads' homes or in the heart failure clinic. The first session 2 weeks after discharge and the two remaining sessions 6- and 12-weeks following discharge. Each session included education on heart failure and development of problem- solving skills to assist the dyads in recognizing and modifying factors that contribute to psychological and emotional distress. The intervention focused on changing thoughts and behaviors and implementing strategies for self-care.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived control measure by Control Attitude Scale	Perceived control in patients and partners	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measure by SF-36	Quality of life in patients and partners	3, 12 and 24 months
Self care measured by European Self-care Behaviour Scale	Self care in patients	3, 12 and 24 months
Caregiverburden measured by Caregiverburden Scale	Caregiverburden in partners	3, 12 and 24 months

Collaborators and Investigators

• Sponsor: Linkoeping University

Publications and helpful links

General Publications

• Liljeroos M, Agren S, Jaarsma T, Stromberg A. Dialogues between nurses, patients with heart failure and their partners during a dyadic psychoeducational intervention: a qualitative study. BMJ Open. 2017 Dec 14;7(12):e018236. doi: 10.1136/bmjopen-2017-018236.
• Liljeroos M, Agren S, Jaarsma T, Arestedt K, Stromberg A. Long-term effects of a dyadic psycho-educational intervention on caregiver burden and morbidity in partners of patients with heart failure: a randomized controlled trial. Qual Life Res. 2017 Feb;26(2):367-379. doi: 10.1007/s11136-016-1400-9. Epub 2016 Sep 8.
• Liljeroos M, Agren S, Jaarsma T, Arestedt K, Stromberg A. Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure. PLoS One. 2015 Sep 25;10(9):e0138058. doi: 10.1371/journal.pone.0138058. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: March 8, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (ESTIMATE): March 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Dnr 03-568