Nurse-led follow-up care for patient relatives at risk for cardiomyopathy

• Register: ISRCTN
• Last refreshed on: 2 September 2019
• Main ID: ISRCTN35774505
• Date of registration: 23/04/2016
• Prospective Registration: No
• Primary sponsor: University Medical Center Groningen (Netherlands)
• Public title: Nurse-led follow-up care for patient relatives at risk for cardiomyopathy
• Scientific title: Follow-up care by a specialized genetic counsellor for patient relatives at risk for cardiomyopathies is cost-saving and well-appreciated: a randomised comparison
• Date of first enrolment: 01/08/2011
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN35774505
• Study type: Interventional
• Study design: Open-label randomized comparison of two different follow-up care modalities for first-degree relatives of index patients at risk for inherited cardiomyopathy (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Karin Nieuwhof

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged > 16 years
2. Relative of patients with DCM/ HCM or mutation carriers
3. Participants must be either:
3.1. Carriers of mutations in the LMNA, DES or PLN genes, who are at a higher prior risk for malignant ventricular arrhythmias compared to other groups; or
3.2. Phenotype-negative relatives (over 16 years of age) of index patients with DCM or HCM with a proven pathogenic mutation and therefore at risk for developing DCM or HCM; or
3.3. Phenotype-negative relatives of index patients with potentially inherited DCM or HCM in whom no pathogenic mutation had been identified

Exclusion criteria:
1. Any signs or symptoms of the disease
2. Presence of other heart diseases
3. A medical history with complex co-morbidity


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiomyopathy
Circulatory System
Cardiomyopathy

Intervention(s)

First-degree relatives of index patients not already known to have a DCM/HCM diagnosis (based on their first screening at a combined Cardiogenetics Clinic), but who are eligible for follow-up according to information from the local patient database, are randomly assigned (1:1) at the beginning of the study and stratified by one of the hospitals to receive one of two care models:

Group 1: Participants receive a cardiogenetics clinic (CGC) appointment. This involves being invited to an appointment and seen by a genetic counsellor. Family history, reproductive options and new diagnostic /treatment options or the results of DNA testing when appropriate, and encouragement for other relatives to have genetic or cardiologic screening are discussed. If the participants consented to predictive DNA testing, the genetic counsellor initiated this procedure immediately after the counselling session. If the genetic counsellor proposed further tests this is discussed immediately (in another room) with the supervising cardiologist (multidisciplinary context) and, in a joint consultation, additional diagnostics were discussed with the patient. The cardiologist later discussed the results of additional diagnostic tests with the participant.

Group 2: Participants receive regular follow-up care by a cardiologist

Follow up for all participants involves ECG, echocardiography, measurement of blood pressure, assessment of the patient and his or her family’s health and, as needed, providing information on DCM/HCM. Guided by the results of the cardiology investigations, according to the protocols and/or the patient/family history, further tests such as a Holter monitor, an exercise stress test or a cardiac MRI took place

Primary Outcome(s)

1. Uptake percentage of follow-up by relatives at either clinic during the study is measured using patient records following each consultation for 1.5 years
2. Perceived Personal Control (PPC) and patient satisfaction are determined using questionnaires following each consultation for 1.5 years
3. Results of supervision (like additional diagnostics, referral to cardiologist, wrong conclusions) are determined using patient records following each consultation for 1.5 years
4. Resource use and cost reductions are determined using patient records after the consult and personnel/ hospital information at 1.5 years

Secondary ID(s)

N/A

Source(s) of Monetary Support

Universitair Medisch Centrum Groningen

Ethics review

Status:
Approval date:
Contact:

The UMCG Medical Ethical Review Committee declared this study to be exempt from formal review and approval (M11.108973)

Results

• Results available: Yes
• Date Completed: 01/04/2013