urse-led follow-up care for patient relatives at risk for cardiomyopathy
- Conditions
- CardiomyopathyCirculatory System
- Registration Number
- ISRCTN35774505
- Lead Sponsor
- niversity Medical Center Groningen (Netherlands)
- Brief Summary
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27901040 (added 09/08/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 189
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
1. Any signs or symptoms of the disease
2. Presence of other heart diseases
3. A medical history with complex co-morbidity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 2. Perceived Personal Control (PPC) and patient satisfaction are determined using questionnaires following each consultation for 1.5 years<br> 3. Results of supervision (like additional diagnostics, referral to cardiologist, wrong conclusions) are determined using patient records following each consultation for 1.5 years<br> 4. Resource use and cost reductions are determined using patient records after the consult and personnel/ hospital information at 1.5 years<br>
- Secondary Outcome Measures
Name Time Method