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Supporting Dyads Affected by Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducational support
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control

    Psycho edcuactional support

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Perceived control measure by Control Attitude Scale
    Perceived control in patients and partners

    Secondary Outcome Measures

    Quality of life measure by SF-36
    Quality of life in patients and partners
    Self care measured by European Self-care Behaviour Scale
    Self care in patients
    Caregiverburden measured by Caregiverburden Scale
    Caregiverburden in partners

    Full Information

    First Posted
    March 8, 2015
    Last Updated
    March 24, 2015
    Sponsor
    Linkoeping University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02398799
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Linkoeping University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Psycho edcuactional support
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducational support
    Intervention Description
    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 Outcome Measure Information:
    Title
    Perceived control measure by Control Attitude Scale
    Description
    Perceived control in patients and partners
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Quality of life measure by SF-36
    Description
    Quality of life in patients and partners
    Time Frame
    3, 12 and 24 months
    Title
    Self care measured by European Self-care Behaviour Scale
    Description
    Self care in patients
    Time Frame
    3, 12 and 24 months
    Title
    Caregiverburden measured by Caregiverburden Scale
    Description
    Caregiverburden in partners
    Time Frame
    3, 12 and 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29247098
    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.
    Results Reference
    derived
    PubMed Identifier
    27631892
    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.
    Results Reference
    derived
    PubMed Identifier
    26406475
    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.
    Results Reference
    derived

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    Supporting Dyads Affected by Heart Failure

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