CoreNAVI - Feasability of a patient navigation programme
Phase 2
- Conditions
- G45I60I61I63I64C34C97H34H47.0Transient cerebral ischaemic attacks and related syndromes
- Registration Number
- DRKS00025476
- Lead Sponsor
- Charité Campus Virchow-Klinikum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 312
Inclusion Criteria
• Confirmed diagnosis of stroke/TIA (ICD-10 Codes: G45.x, I60.x, I61.x, I63.x, I64.x, H34.x, H47.0)
• Confirmed diagnosis of lung cancer (ICD-10 Codes: C34.1, C34.2, C34.3, C34.8, C34.9, C97)
• caregiver of a patient with stroke/lung cancer (after consent of the patient or if legal guardianship consists)
• Age: =18 years
• living in Berlin or Brandenburg
Exclusion Criteria
• patients living in nursing care facility
• patient without caregiver and not able to give informed consent and for which no legal guardianship is in place
• dementia (inclusion of caregiver may be possible)
• language barrier (inclusion of caregiver may be possible)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A) <br>Feasibility of the intervention with two indicators: (1) At least 70% of patients randomized to the intervention arm have received at least one initial in-person navigator session, (2) The drop-out rate from the intervention arm of the RCT is less than 40% within one year.<br><br>B) <br>In case these feasibility criteria are met, we will test the efficacy of the intervention. The primary efficacy endpoint is Satisfaction with healthcare (single item with 5-point likert response scale) at the final follow-up (13 months after baseline, 12 month after the start of the intervention).
- Secondary Outcome Measures
Name Time Method