Cleft lip and/or palate Other
Conditions
Interventions
STUDY DESIGN AND SETTING:
Cleft@18-23 Research Clinics is a multi-centre cross-sectional cohort study to be conducted across all UK NHS regional cleft centres. The populations served by these centres
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 23 Years
Inclusion criteria
Inclusion criteria: Broad inclusion criteria will be applied such that young adults aged 18-23 years with any cleft subtype, with or without an identified syndrome and additional needs, will be eligible. 1. Born with a cleft of the lip or palate or both (including microform cleft lip and submucous cleft palate) 2. Initial cleft repair carried out in the UK prior to age 2 years 3. Cleft care continued in the UK since the primary repair 4. Aged between 18 and 23 years at the time of recruitment 5. Completed routine cleft care more than 6 months ago 6. Ability to give informed consent
Exclusion criteria
Exclusion criteria: 1. Received any cleft treatment outside of the UK
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Limitation in usual role activities because of emotional problems, measured using the subscale from the Short Form 36 (SF36) on a self-report questionnaire at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured on a self-report questionnaire at baseline: 1. Satisfaction with appearance and function measured using the CLEFT-Q 2. Depression measured using the Patient Health Questionnaire (PHQ-8) 3. Anxiety measured using Generalised Anxiety Disorder (GAD-7) 4. Resilience measured using Connor-Davidson Resilience Scale (CD-RISC-10) 5. Health literacy measured using the Health Literacy Questionnaire (HLS-Q12) 6. Satisfaction with oral health measured using Oral Health Impact Profile (OHIP-14) 7. Productivity loss (measure of health economics) measured using Work Productivity and Activity Impairment (WPAI) 8. Economic impact on health resources measured using Modular Resource Use Measure (ModRUM) 9. Social functioning measured using the Harter Self-Perception Profile 10. Worldview and life orientation measured using the Life Orientation Test (LOT-R) 11. Global health-related quality of life measured using Patient Reported Outcome Measurement Information System (PROMIS) Measured by clinical assessment at baseline: 1. Nasolabial appearance assessed using the Asher McDade score (from photos) 2. Facial shape assessed using 3D score (from 3D images) 3. Hearing assessed using pure tone audiometry 4. Speech assessed using CAPS-A analysis (of video recordings) 5. Dental arch alignment assessed using the Modified Huddard Bodenham Index (MHBI)(from intra-oral scans) 6. Dental occlusion assessed using Peer Assessment Rating (PAR) scores (from intra-oral scans) 7. Dental caries assessed using Decayed and Filled Teeth (DFT/T) 8. Periodontal health assessed using the Community Periodontal Index of Treatment Need (CPITN) and Modified Plaque Index (MPS) | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Outcome results
None listed