Supporting Dyads Affected by Heart Failure
1 other identifier
interventional
155
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Jan 2005
Longer than P75 for not_applicable heart-failure
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedMarch 26, 2015
March 1, 2015
4.2 years
March 8, 2015
March 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Perceived control measure by Control Attitude Scale
Perceived control in patients and partners
3 months
Secondary Outcomes (3)
Quality of life measure by SF-36
3, 12 and 24 months
Self care measured by European Self-care Behaviour Scale
3, 12 and 24 months
Caregiverburden measured by Caregiverburden Scale
3, 12 and 24 months
Study Arms (2)
control
NO INTERVENTIONThe 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.
Psycho edcuactional support
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- drug abuse,
- difficulties in understanding or reading the Swedish language,
- undergoing cardiac surgery including cardiac transplant or
- participating in other studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 29247098DERIVEDLiljeroos 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.
PMID: 27631892DERIVEDLiljeroos 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.
PMID: 26406475DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 8, 2015
First Posted
March 26, 2015
Study Start
January 1, 2005
Primary Completion
March 1, 2009
Study Completion
December 1, 2010
Last Updated
March 26, 2015
Record last verified: 2015-03