Clinical trial NCT02398799: Supporting Dyads Affected by Heart Failure
Official title: Supporting Dyads Affected by Heart Failure - A Randomised Controlled Study Evaluating a Psychoeducational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2015-03-26
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Perceived control measure by Control Attitude Scale
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life measure by SF-36
timeFrame: 3, 12 and 24 months
measure: Self care measured by European Self-care Behaviour Scale
timeFrame: 3, 12 and 24 months
measure: Caregiverburden measured by Caregiverburden Scale
timeFrame: 3, 12 and 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.