G45 I60 I61 I63 I64 C34 C97 H34 H47.0
Conditions
Interventions
Group 1: Intervention arm: Participants will receive support of a personal patient navigator for 1 year
Group 2: Control arm: Participants will receive a broschure with regional support offers for pat
Sponsors
Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A) 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. B) 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
| Measure | Time frame |
|---|---|
| A Feasibility of the intervention: 1. Acceptance: % eligible patients interested to receive the navigator intervention; % consenting to the RCTs; % interested but unwilling to be randomized; % patients randomized and starting the intervention; % patients adhering to the appointments with navigator; % patients and % navigators ‚very satisfied‘ or ‚satisfied‘ with the intervention; 2. Demand: Support needs; Number of Navigator contacts; Delivery mode of the navigator interaction (in-person, phone, email, other); Type of navigator services performed; 3. Implementation and Practicality: % of target population (potentially eligible patients) approached and informed about study at recruitment centers before discharge; % patient-navigator appointments carried out as planned; % of individual patient goals achieved B) Efficacy of the intervention: 1. Quality of life and functional status (EQ-5D_5L, PHQ-4 , EORTC QLQ-LC29 (only cancer patients), Barthel-Index (only stroke patients)) At all follow-up time points (4, 7 and 13 months after baseline) 2. Healthcare utilization, delayed care, forgone Care At all follow-up time points (4, 7 and 13 months after baseline) 3. Information needs At all follow-up time points (4, 7 and 13 months after baseline) 4. Health literacy At all follow-up time points (4, 7 and 13 months after baseline) 5. Satisfaction with different aspects of healthcare At all follow-up time points (4, 7 and 13 months after baseline) 6. Trust in medical care At all follow-up time points (4, 7 and 13 months after baseline) 7. Self-efficacy At all follow-up time points (4, 7 and 13 months after baseline) 8. Supportive care needs At all follow-up time points (4, 7 and 13 months after baseline) 9. Social support, loneliness At all follow-up time points (4, 7 and 13 months after baseline) 10. Self-reported medication adherence At all follow-up time points (4, 7 and 13 months after baseline) 11. Participation in rehabilitation and | — |
Countries
Germany
Contacts
Public ContactKathrin Gödde
Charité-Universitätsmedizin Berlin, Institut für Public Health
Outcome results
None listed