Peer-delivered psychosocial support for patients with rare autoimmune liver diseases
Not Applicable
- Conditions
- Rare autoimmune liver diseases, i.e. autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC)Digestive System
- Registration Number
- ISRCTN15030282
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36964518/ (added 27/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 472
Inclusion Criteria
Effectiveness focus:
1. Autoimmune rare liver disease (AIH, PSC, PBC)
2. Subjective psychosocial support need
3. =18 years
4. Written informed consent
Implementation focus:
Patients:
see above
Stakeholders:
1. Involvement in intervention delivery/implementation i.e. healthcare providers, patient representatives, health insurers
2. Written informed consent
Exclusion Criteria
Effectiveness focus:
1. Life-threatening health-status
2. Acute suicidality
3. Ongoing psychotherapy
4. Severe cognitive, auditory or visual impairment
5. Inability to complete assessments
Implementation focus:
1. Involvement in outcome assessment or data analysis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Effectiveness outcomes will be assessed at baseline, after the program and at a 3-month follow-up. Our primary effectiveness outcome is the baseline-adjusted group difference in mental health-related quality of life directly after the intervention, measured with the Short Form Health Survey (SF-12).<br> 2. Quantitative implementation outcomes will be assessed at post-assessment. Qualitative implementation outcomes after the follow-up assessment. Our primary implementation outcomes are acceptability and feasibility of the program, operationalized by completion rate and subjective rating of appropriateness, helpfulness, and feasibility on numeric rating scales from 0-10.<br>
- Secondary Outcome Measures
Name Time Method