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NCT05793411: Carmac
Risk Behaviors in Adolescents With Chronic Diseases
trial testing Questionnaire risk behaviors in adolescents with chronic diseases in Chronic Disease in 500 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 January 2023 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Questionnaire risk behaviors in adolescents with chronic diseases
Conditions studied
- Chronic Disease — all drugs for Chronic Disease →
- Somatic Disorders — all drugs for Somatic Disorders →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 14 to 18, any sex, with Chronic Disease or Somatic Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Little is known about the prevalence of risk behaviors (RBs), in adolescents living with a chronic condition (CC) Objectives Main objective: To characterize the engagement of adolescents with somatic CC recognized as ALD (SCC-ALD) into RBs, compared to the French GP Secondary objectives * To identify factors associated with RBs in adolescents with somatic CC-ALD * To elicit strategies of preventive action of RBs in adolescents with somatic CC-ALD Methods multicenter, cross-sectional survey , based on a mixed qualitative-quantitative approach with an explanatory sequential design (2 consecutive steps): STEP 1 : QUANTITATIVE COMPONENT * N expected =500 * Inclusion criteria : 14 to 18 years, With a SCC-ALD,Without cognitive impairment and/or psychiatric disease * Pseudonymised self-administered paper questionnaire (50 items) completed by eligible adolescents during a visit at referring hospital * statistical analysis : Comparative to the French GP: matching with two datasets (Enclass-HBSC 2022 and Portraits d'Adolescents 2013 surveys); identification of risk factors and risk subgroups STEP 2 : QUALITATIVE COMPONENT: Focus groups of adolescents with somatic CC-ALD (5 focus groups of 6-8 adolescents, conducted by a researcher in SHS) Perspectives CARMAC will : * Provide a better understanding of RBs in adolescents with severe somatic CC and * Help develop strategies to prevent RBs to enhance the strategies of reducing the addictions to psychoactive substances and health inequalities in this population * Serve as a methodological model for future studies
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05793411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05793411 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 31 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05793411.
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