Advance Care Planning in Patients With Heart Failure in Denmark

NCT05269875 | Completed DMC

• 1 other identifier: ACP-P-2020-790
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Advance care planning (ACP) represents a process whereby a patient, in consultation with healthcare professionals, family members and important others, makes decisions about his or her future healthcare and wishes for end-of-life care and is widely advocated to improve end-of-life care for patients with heart failure (HF). Despite the growing emphasis on communication with HF patients and their relatives, there is no tradition in Denmark for systematical communication about wishes for end-of-life care. The aim of the study is to adapt the ACP to a new contest and target group and determine the feasibility and acceptable recruitment rate and completeness of potential outcome measures for a future RCT. A study of a complex intervention will be conducted to address all elements of an adapted ACP intervention in HF patients (NYHA class III, IV) and their relatives. Patients will be identified and recruited by HF specialist nurses or a cardiologist from the Department of Cardiology at North Zealand Hospital. The HF specialist nurses or the cardiologist will inform the patients about the study and obtain consent for the research staff to contact the patients by telephone. The patients will be further informed by the research staff and asked to fill out the baseline questionnaires. The patients will be asked to select the closest relatives who also will be offered participation. Included patients will receive an invitation with the date and time of their ACP meeting in their electronic patient record. They will be offered an ACP discussion which covers components e.g. symptom control, discussions on prognosis and illness limitations, and wishes for future and end-of-life care. Baseline and follow-up (4 and 12 weeks after the ACP meeting) will be made with disease-specific and generic questionnaires. Qualitative interview data will be obtained, and thematic analysis will uncover the patients, relatives and the clinician's perspectives and satisfaction with the intervention.

Conditions

Heart Failure; Advance Care Planning; Communication; Feasibility Studies

Keywords

Heart Failure; Advance care planning; Feasibility study; Adaptation; Complex intervention; Communication

Outcome Measures

Primary Outcomes (4)

• Change in Quality of life

  • The European Organisation for Research and Treatment of Cancer Quality of life - Questionnaire - (EORTC QLQ-C15-PAL) to assess several physical and psychosocial aspects of the patient's health-related quality of life. Each question is rated on a Likert scale from 1 (not at all) to 4 (very much) excluding global health status, which is rated from 1 (very poor) to 7 (excellent).

  Baseline, after 4 and 12 weeks

• Change in Quality of life and heart related symptoms

  • HeartQol to assess health-related quality of life in patients with heart disease. Each question is scored on a 4-point Likert scale from 0-3. The higher score, the less the respondent is bothered by his heart problem, which means a higher quality of life.

  Baseline, 4 and 12 weeks

• Change in Fatique

  • Multidimensional Fatigue Interventory (MFI-20) to determining the quality and patterns of sleep. The items are rated on agreement with statements (Yes, that is true - No, that is not true) covering five dimensions of fatigue. Range 4-20. Higher scores indicate greater fatigue.

  Baseline, 4 and 12 weeks

• Change in Anxiety and depression

  • Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression in medically ill patients. A 14 items in two sub-scales (anxiety: HADS-A; depression: HADS-D). Total subscale scores range: 0-21. Both subscale scores can be interpreted as follows: 0-7 points is considered within normal range, 8-10 is suggestive of the mood disorder, ≥8 indicating probable presence of the mood disorder.

  Baseline, 4 and 12 weeks

Secondary Outcomes (6)

• Use of healthcare system-patients' assessment

  During the past 12 months from intervention.

• Change in Dyadic coping-patients and caregivers' assessment

  Baseline, 4 and 12 weeks

• Change in Caregiver burden -caregivers' assessment

  Baseline, 4 and 12 weeks

• Change in Health-related quality of life-patients and caregivers' assessment

  Baseline, 4 and 12 weeks

• Satisfaction with the intervention - interview with patients and caregivers

  Maximum 2 weeks after the ACP intervention

Study Arms (1)

Advance care planning in heart failure patients

OTHER

The patient and their closest relative will be offered a palliative care intervention by the Department of Cardiology.

Other: ACP

Interventions

ACP OTHER

The intervention covers a formal ACP discussion, including provision of a holistic approach (physical, psychological, spiritual, social) and includes symptom control and discussion on illness limitations and prognosis, goal assessment and goal adjustment, financial issue, (un)desirable treatments for current and future care, hopes and wishes, and possibility of involvement of a palliative care team.

Advance care planning in heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Able to speak and understand Danish
• Not expected to die within 1 month assessed by a cardiologist or a heart failure specialist nurse
• Cognitively able to participate in the intervention
• Disease specific criteria - patients (minimum two must be fulfilled):
• Classified as being in NYHA III-IV by a cardiologist or heart failure specialist nurse and documented in the patient record.
• Progressive functional decline (physical and mental) and dependence in most activities of daily living based on clinical assessment by a cardiologist or a heart failure specialist nurse.
• Severe symptoms despite optimal pharmacological and non-pharmacological treatment assessed by a cardiologist or a heart failure specialist nurse.
• Two or more acute episodes that required admission to hospital over the last 6 months including the current admission.
• Heart transplantation and mechanical circulatory support (MCS) ruled out.
• Cardiac cachexia assessed clinically defined as a 'complex metabolic syndrome associated with underlying illness and characterized by loss of muscle with or without loss of fat mass'.
• Clinically judged by a cardiologist, palliative specialist or heart failure specialist nurse to have a life expectancy within 1-12 month.
• At least 18 years of age

You may not qualify if:

• Unable to speak or communicate in Danish
• Cognitively unable to participate to collaboration and complete questionnaires

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Rigshospitalet, Denmark: collaborator
• University of Southern Denmark: collaborator
• Odense University Hospital: collaborator
• Zealand University Hospital: collaborator
• REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care: collaborator

Study Sites (1)

Department of Cardiology, North Zeeland Hospital

Hillerød, 3500, Denmark

Location

Related Publications (1)

• Roin T, Jurlander B, Juhl GI, Dieperink KB, Sjogren P, Bergenholtz H, Zwisler AD, Kurita GP, Larsen S, Tonder N, Hoyer LV, Lykke C. Taking a stand, ready or not: navigating sensitive end-of-life care conversations in patients with end-stage heart failure. Eur J Cardiovasc Nurs. 2025 Apr 11;24(3):401-410. doi: 10.1093/eurjcn/zvae170.

  PMID: 39762160 DERIVED

MeSH Terms

Conditions

Heart Failure; Communication

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Camilla Lykke, Postdoc

  Department of Oncology and palliative Care and the Department of Cardiology, North Zeeland Hospital

  PRINCIPAL INVESTIGATOR

• Camilla Lykke, Postdoc

  Department of Oncology and palliative Care and the Department of Cardiology, North Zeeland Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Postdoc

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 8, 2022
• Study Start: February 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

DK (1)