search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Timely recognition of palliative care needs of patients with advanced chronic heart failure: Translation, adaptation and feasibility testing of the Dutch version of the ‘Needs Assessment Tool: Progressive Disease – Heart Failure (NAT: PD-HF)’


- candidate number23567
- NTR NumberNTR5616
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2016
- Secondary IDs 
- Public TitleTimely recognition of palliative care needs of patients with advanced chronic heart failure: Translation, adaptation and feasibility testing of the Dutch version of the ‘Needs Assessment Tool: Progressive Disease – Heart Failure (NAT: PD-HF)’
- Scientific TitleTimely recognition of palliative care needs of patients with advanced chronic heart failure: Translation, adaptation and feasibility testing of the Dutch version of the ‘Needs Assessment Tool: Progressive Disease – Heart Failure (NAT: PD-HF)’
- ACRONYMDutc NAT:PD-HF
- hypothesisWe hypothesize a priori that the Dutch NAT: PD-HF will be a feasible and acceptable tool to identify palliative care needs in patients with CHF and will initiate appropriate management.
- Healt Condition(s) or Problem(s) studiedChronic Heart Failure
- Inclusion criteriaIn order to be eligible to participate in this study, a patient must meet all of the following criteria:
- a diagnosis of CHF according to the European Society of Cardiology (ESC) guidelines[22];
- receiving a home visit by a heart failure nurse specialist of the Maastricht UMC+, Maastricht, the Netherlands. Patients who receive a home visit are in general patients with severe CHF for whom a visit to the cardiologist or heart failure nurse specialist in the hospital is too burdensome;
- classified as NYHA III or IV;
- able to complete written questionnaires or participate in interviews;
- able to provide informed consent.

Family caregivers must meet all of the following criteria:
- provide assistance and support;
- able to complete a written questionnaire;
- able to provide informed consent.
- Exclusion criteriaA patient already referred to the palliative care team within the previous 6 months will be excluded from participation in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate
- Target number of participants30
- InterventionsHeart failure nurse specialists will complete the NAT: PD-HF during a regular home visit. The NAT: PD-HF is a one-page assessment tool that can be completed by healthcare professionals across a range of disciplines.(Waller et al. 2013)
- Primary outcome1. acceptability of the NAT: PD-HF according to the heart failure nurse specialist using a numeric rating scale (NRS) and option of free text feedback;
2. completeness of clinician completion of the NAT: PD-HF;
3. time to complete the NAT: PD-HF.
- Secondary outcome1. Recruitment rate of patients and their carers and attrition at four month follow-up;
2. Change, from baseline at 4 four months in symptom burden (Dutch version of the Edmonton Symptom Assessment Scale, (ESAS)[24]);
3. Change, from baseline at 4 four months in Australia-modified Karnofsky Performance Status (AKPS) scale[25];
4. Change, from baseline at 4 four months in disease-specific health status (Minnesota Living with Heart Failure Questionnaire (MLHFQ)[26]);
5. Change, from baseline at 4 four months in caregiver burden and positive aspects of caregiving (Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC)[27]);
6. Change, from baseline at 4 four months in Care dependency (Care Dependency Scale (CDS)[28]);
7. Evidence of documented advance care planning;
8. Health service utilisation (including number of consultations with any member of the palliative care team, hospital admissions and emergency room visits) during the study period;
9. If patients die during the study period: the place of death will be recorded;
10. If patients received a palliative care consult: identified problems and management (chart review of PRADO, the electronic patient file of the Dutch Palliative Care teams);
11. Referral rate to palliative care, and the concern(s) as the cause of referral;
12. Referral to other services.
- Timepointsbaseline and 4 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Daisy J.A. Janssen
- CONTACT for SCIENTIFIC QUERIESMD. Daisy J.A. Janssen
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Stoffels-Hornstra Foundation
- Publications
- Brief summaryRationale: In patients with advanced Chronic Heart Failure (CHF), palliative care needs remain frequently unrecognized and palliative care consultations are not routinely incorporated in clinical care, despite their potential benefit. Recently, the ‘Needs Assessment Tool: Progressive Disease – Heart Failure (NAT:PD-HF)’ has been developed with the potential to be used as part of a strategy to identify and triage the management of palliative care needs experienced by people with CHF.[1] To date, a Dutch version of the NAT: PD-HF is not available and the feasibility, acceptability and impact of this tool is unknown.

Objective: To study the feasibility and acceptability of the use of the NAT: PD-HF among outpatients with advanced CHF and to gain preliminary data regarding the effect of the NAT: PD-HF on patient and caregiver palliative care needs.

Study design: a single centre feasibility study.

Study population: 30 consecutive outpatients with a diagnosis of advanced CHF (New York Heart Association class III or IV) who receive a home visit by a heart failure nurse specialist of the Maastricht UMC+, Maastricht, the Netherlands and their family caregivers.

Intervention: The heart failure nurse specialist will complete the translated and adapted NAT: PD-HF during a usual clinical care home visit with the patient.

Main study parameters/endpoints: acceptability of the NAT: PD-HF according to nurses; recruitment rate of patients and their carers; completeness of nurses completion of the NAT: PD-HF; and time to complete the NAT: PD-HF.

Nature and extent of the burden and risks associated with participation and benefit: The study includes two home visits of about one hour during which participants are asked to complete questionnaires and/or interviews. Burden for patients will be low, because all interviews are done using home visits and questionnaires have been kept to a minimum and short-forms used where possible. Participation might be beneficial because palliative care needs will be assessed and addressed if present.
- Main changes (audit trail)
- RECORD5-jan-2016 - 19-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl