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NCT Number: NCT05116514

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

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Key information

Conditions

Psychotic Episode

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de TOULOUSE, Toulouse, Choisir Une Région, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient or their close relative must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a 3-year follow-up.
  • Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:
  • Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
  • Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
  • A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
  • Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
  • At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Exclusion criteria

  • The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
  • The subject, or one of the parents for minor patients, refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patients has an IQ less than or equal to 55
  • The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
  • The patient is pregnant or breastfeeding

Treatment and study plan

Case management

Other

Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Primary outcomes

  1. Rate of patients with recurrence of psychotic episode at least once between groups

    Time frame: 3 years

    Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

Secondary outcomes

  1. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    Time frame: 1 year

    number

  2. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    Time frame: 2 years

    number

  3. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    Time frame: 3 years

    number

  4. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    Time frame: 1 year

    number

  5. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    Time frame: 2 years

    number

  6. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    Time frame: 3 years

    number

  7. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    Time frame: 1 year

    days/weeks/months

  8. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    Time frame: 2 years

    days/weeks/months

  9. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    Time frame: 3 years

    days/weeks/months

  10. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: Inclusion

    %

  11. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 6 months

    %

  12. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 1 year

    %

  13. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 18 months

    %

  14. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 2 years

    %

  15. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 2.5 years

    %

  16. Percentage per patient of medical and caregiving appointments honored between groups

    Time frame: 3 years

    %

  17. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: Inclusion

    % voluntary versus involuntary

  18. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 6 months

    % voluntary versus involuntary

  19. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 1 year

    % voluntary versus involuntary

  20. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 18 months

    % voluntary versus involuntary

  21. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 2 years

    % voluntary versus involuntary

  22. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 2.5 years

    % voluntary versus involuntary

  23. Type of hospital admission (voluntary versus involuntary) between groups

    Time frame: 3 years

    % voluntary versus involuntary

  24. Unscheduled discharge from care between groups

    Time frame: Inclusion

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  25. Unscheduled discharge from care between groups

    Time frame: 6 months

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  26. Unscheduled discharge from care between groups

    Time frame: 1 year

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  27. Unscheduled discharge from care between groups

    Time frame: 18 months

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  28. Unscheduled discharge from care between groups

    Time frame: 2 years

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  29. Unscheduled discharge from care between groups

    Time frame: 2.5 years

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  30. Unscheduled discharge from care between groups

    Time frame: 3 years

    Defined by a break in follow-up organized by the referring care team for more than 30 days

  31. Treatment compliance between groups

    Time frame: Inclusion

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  32. Treatment compliance between groups

    Time frame: 6 months

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  33. Treatment compliance between groups

    Time frame: 1 year

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  34. Treatment compliance between groups

    Time frame: 18 months

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  35. Treatment compliance between groups

    Time frame: 2 years

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  36. Treatment compliance between groups

    Time frame: 2.5 years

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  37. Treatment compliance between groups

    Time frame: 3 years

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

  38. Adherence to treatment

    Time frame: 1 year

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

  39. Adherence to treatment

    Time frame: 2 years

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

  40. Adherence to treatment

    Time frame: 3 years

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

  41. Therapeutic alliance

    Time frame: 1 year

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

  42. Therapeutic alliance

    Time frame: 2 years

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

  43. Therapeutic alliance

    Time frame: 3 years

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

  44. Patient awareness of disorders and of the need for treatment

    Time frame: 1 year

    Birchwood Insight Scale (BIS, self-administered questionnaire)

  45. Patient awareness of disorders and of the need for treatment

    Time frame: 2 years

    Birchwood Insight Scale (BIS, self-administered questionnaire)

  46. Patient awareness of disorders and of the need for treatment

    Time frame: 3 years

    Birchwood Insight Scale (BIS, self-administered questionnaire)

  47. Assessment of addictive comorbidities

    Time frame: Inclusion

    semi-structured clinical interview for DSM (SCID)

  48. Assessment of addictive comorbidities

    Time frame: 3 years

    semi-structured clinical interview for DSM (SCID)

  49. Assessment of tobacco, alcohol and drug use

    Time frame: Every 6 months from inclusion

    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

  50. Evaluation of the clinical impact of the intervention between groups

    Time frame: Every 6 months from inclusion

    Clinical Global Impression questionnaire (CGI)

  51. Psychotic and general symptoms

    Time frame: Every 6 months from inclusion

    Positive and Negative Symptom Scale (PANSS)

  52. Depressive symptoms

    Time frame: Every 6 months from inclusion

    Calgary Depression Scale for Schizophrenia (CDSS)

  53. Self- and hetero-aggressive behaviors

    Time frame: Every 6 months from inclusion

    according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2

  54. Reported adverse events

    Time frame: Inclusion

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  55. Reported adverse events

    Time frame: 6 months

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  56. Reported adverse events

    Time frame: 1 year

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  57. Reported adverse events

    Time frame: 18 months

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  58. Reported adverse events

    Time frame: 2 years

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  59. Reported adverse events

    Time frame: 2.5 years

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  60. Reported adverse events

    Time frame: 3 years

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

  61. Current suicidal ideations

    Time frame: Inclusion

    Calgary Depression Scale for Schizophrenia (CDSS)

  62. Current suicidal ideations

    Time frame: 6 months

    Calgary Depression Scale for Schizophrenia (CDSS)

  63. Current suicidal ideations

    Time frame: 1 year

    Calgary Depression Scale for Schizophrenia (CDSS)

  64. Current suicidal ideations

    Time frame: 18 months

    Calgary Depression Scale for Schizophrenia (CDSS)

  65. Current suicidal ideations

    Time frame: 2 years

    Calgary Depression Scale for Schizophrenia (CDSS)

  66. Current suicidal ideations

    Time frame: 2.5 years

    Calgary Depression Scale for Schizophrenia (CDSS)

  67. Current suicidal ideations

    Time frame: 3 years

    Calgary Depression Scale for Schizophrenia (CDSS)

  68. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: Inclusion

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  69. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 6 months

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  70. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 1 year

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  71. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 18 months

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  72. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 2 years

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  73. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 2.5 years

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  74. Assess the impact of the intervention on socio-professional functioning and quality of life

    Time frame: 3 years

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

  75. Social and occupational functioning

    Time frame: Inclusion

    Social and Occupational Functioning Assessment Scale (SOFAS)

  76. Social and occupational functioning

    Time frame: 6 months

    Social and Occupational Functioning Assessment Scale (SOFAS)

  77. Social and occupational functioning

    Time frame: 1 year

    Social and Occupational Functioning Assessment Scale (SOFAS)

  78. Social and occupational functioning

    Time frame: 18 months

    Social and Occupational Functioning Assessment Scale (SOFAS)

  79. Social and occupational functioning

    Time frame: 2 years

    Social and Occupational Functioning Assessment Scale (SOFAS)

  80. Social and occupational functioning

    Time frame: 2.5 years

    Social and Occupational Functioning Assessment Scale (SOFAS)

  81. Social and occupational functioning

    Time frame: 3 years

    Social and Occupational Functioning Assessment Scale (SOFAS)

  82. Social functioning

    Time frame: Inclusion

    Health of the Nation Outcome Scales

  83. Social functioning

    Time frame: 6 months

    Health of the Nation Outcome Scales

  84. Social functioning

    Time frame: 1 year

    Health of the Nation Outcome Scales

  85. Social functioning

    Time frame: 18 months

    Health of the Nation Outcome Scales

  86. Social functioning

    Time frame: 2 years

    Health of the Nation Outcome Scales

  87. Social functioning

    Time frame: 2.5 years

    Health of the Nation Outcome Scales

  88. Social functioning

    Time frame: 3 years

    Health of the Nation Outcome Scales

  89. Psychosocial functioning

    Time frame: Inclusion

    Quality of Life Scale (QLS) - semi-structured interview

  90. Psychosocial functioning

    Time frame: 6 months

    Quality of Life Scale (QLS) - semi-structured interview

  91. Psychosocial functioning

    Time frame: 1 year

    Quality of Life Scale (QLS) - semi-structured interview

  92. Psychosocial functioning

    Time frame: 18 months

    Quality of Life Scale (QLS) - semi-structured interview

  93. Psychosocial functioning

    Time frame: 2 years

    Quality of Life Scale (QLS) - semi-structured interview

  94. Psychosocial functioning

    Time frame: 2.5 years

    Quality of Life Scale (QLS) - semi-structured interview

  95. Psychosocial functioning

    Time frame: 3 years

    Quality of Life Scale (QLS) - semi-structured interview

  96. Functioning

    Time frame: Inclusion

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  97. Functioning

    Time frame: 6 months

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  98. Functioning

    Time frame: 1 year

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  99. Functioning

    Time frame: 18 months

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  100. Functioning

    Time frame: 2 years

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  101. Functioning

    Time frame: 2.5 years

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  102. Functioning

    Time frame: 3 years

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

  103. Quality of life of users (patient and family)

    Time frame: 1 year

    World Health Organization Quality of Life brief (WHOQOL-brief)

  104. Quality of life of users (patient and family)

    Time frame: 2 years

    World Health Organization Quality of Life brief (WHOQOL-brief)

  105. Quality of life of users (patient and family)

    Time frame: 3 years

    World Health Organization Quality of Life brief (WHOQOL-brief)

  106. Health-related quality of life

    Time frame: 1 year

    EuroQol-5D 3 level version (EQ-5D-35L)

  107. Health-related quality of life

    Time frame: 2 years

    EuroQol-5D 3 level version (EQ-5D-35L)

  108. Health-related quality of life

    Time frame: 3 years

    EuroQol-5D 3 level version (EQ-5D-35L)

  109. Quality of life of relatives

    Time frame: 1 year

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

  110. Quality of life of relatives

    Time frame: 2 years

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

  111. Quality of life of relatives

    Time frame: 3 years

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

  112. Cost-outcome type ratio

    Time frame: 3 years

    the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D

  113. Cost of care

    Time frame: 3 years

    assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)

  114. Budget impact analysis between strategies

    Time frame: 3 years

    National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies

  115. Psychiatric assessment

    Time frame: Inclusion

    Structured Clinical Interview for DSM

  116. Psychiatric assessment

    Time frame: 3 years

    Structured Clinical Interview for DSM

  117. Patient age

    Time frame: Inclusion

  118. Patient sex

    Time frame: Inclusion

  119. Current patient professional/training situation

    Time frame: Over the study until 3 years

    working or studying

  120. Financial situation

    Time frame: Over the study until 3 years

  121. Care pathways taken by patient

    Time frame: Over the study until 3 years

    specialist care sought

  122. Duration of non-treated psychosis

    Time frame: Inclusion

    Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment

  123. Personal and family psychiatric history

    Time frame: Inclusion

  124. Social and academic function

    Time frame: Inclusion

    Premorbid Adjustment Scale

  125. Medical treatment received

    Time frame: Until 3 years

  126. Cerebral imagery

    Time frame: Inclusion

    Normal/abnormal

  127. Cerebral imagery

    Time frame: 1 year

    Normal/abnormal

  128. Cerebral imagery

    Time frame: 2 years

    Normal/abnormal

  129. IQ profile

    Time frame: Inclusion

    Homogenous/heterogenous

  130. IQ profile

    Time frame: 1 year

    Homogenous/heterogenous

  131. IQ profile

    Time frame: 2 years

    Homogenous/heterogenous

  132. IQ

    Time frame: Inclusion

    value

  133. IQ

    Time frame: 1 year

    value

  134. IQ

    Time frame: 2 years

    value

  135. BMI

    Time frame: Inclusion

    kg/m2

  136. BMI

    Time frame: 1 year

    kg/m2

  137. BMI

    Time frame: 2 years

    kg/m2

  138. Fasting glycemia

    Time frame: Inclusion

    mmol/l

  139. Fasting glycemia

    Time frame: 1 year

    mmol/l

  140. Fasting glycemia

    Time frame: 2 years

    mmol/l

  141. Lipid assessment

    Time frame: Inclusion

    Normal/abnormal

  142. Lipid assessment

    Time frame: 1 year

    Normal/abnormal

  143. Lipid assessment

    Time frame: 2 years

    Normal/abnormal

  144. Whole blood count

    Time frame: Inclusion

    Normal/abnormal

  145. Whole blood count

    Time frame: 1 year

    Normal/abnormal

  146. Whole blood count

    Time frame: 2 years

    Normal/abnormal

  147. Electrolytes

    Time frame: Inclusion

    Normal/abnormal

  148. Electrolytes

    Time frame: 1 year

    Normal/abnormal

  149. Electrolytes

    Time frame: 2 years

    Normal/abnormal

  150. Neurological exam

    Time frame: Inclusion

    Normal/abnormal

  151. Neurological exam

    Time frame: 1 year

    Normal/abnormal

  152. Neurological exam

    Time frame: 2 years

    Normal/abnormal

  153. Cardiovascular exam

    Time frame: Inclusion

    Normal/abnormal

  154. Cardiovascular exam

    Time frame: 1 year

    Normal/abnormal

  155. Cardiovascular exam

    Time frame: 2 years

    Normal/abnormal

  156. Morphological exam

    Time frame: Inclusion

    Normal/abnormal

  157. Morphological exam

    Time frame: 1 year

    Normal/abnormal

  158. Morphological exam

    Time frame: 2 years

    Normal/abnormal

  159. Hepatic exam

    Time frame: Inclusion

    Normal/abnormal

  160. Hepatic exam

    Time frame: 1 year

    Normal/abnormal

  161. Hepatic exam

    Time frame: 2 years

    Normal/abnormal

  162. Presence of neurometabolic disease

    Time frame: Inclusion

    Yes/no

  163. Presence of neurometabolic disease

    Time frame: 1 year

    Yes/no

  164. Presence of neurometabolic disease

    Time frame: 2 years

    Yes/no

  165. Electrocardiogram

    Time frame: Inclusion

    Normal/abnormal

  166. Electrocardiogram

    Time frame: 1 year

    Normal/abnormal

  167. Electrocardiogram

    Time frame: 2 years

    Normal/abnormal

  168. C-reactive protein

    Time frame: Inclusion

    mg/l

  169. C-reactive protein

    Time frame: 1 year

    mg/l

  170. C-reactive protein

    Time frame: 2 years

    mg/l

  171. thyroid-stimulating hormone

    Time frame: Inclusion

    mUI/l

  172. thyroid-stimulating hormone

    Time frame: 1 year

    mUI/l

  173. thyroid-stimulating hormone

    Time frame: 2 years

    mUI/l

  174. Cortisol

    Time frame: Inclusion

    nmol/l

  175. Cortisol

    Time frame: 1 year

    nmol/l

  176. Cortisol

    Time frame: 2 years

    nmol/l

  177. Adverse events

    Time frame: Inclusion

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

  178. Adverse events

    Time frame: 1 year

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

  179. Adverse events

    Time frame: 2 years

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

  180. Non-medical treatment received

    Time frame: Until 3 years

    Psychosocial/psychotherapy interventions

  181. In the experimental group: case management according to good practice guidelines

    Time frame: End of follow-up (3 years)

    EPPIC Model Integrity Tool (80 items with subscores)

  182. In the experimental group: Conformity of case management

    Time frame: End of study (5 years)

    Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)

  183. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: Month 3

    TIDieR checklist-patient

  184. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: Month 6

    TIDieR checklist-patient

  185. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: 1 year

    TIDieR checklist-patient

  186. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: 18 Months

    TIDieR checklist-patient

  187. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: 2 years

    TIDieR checklist-patient

  188. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: 30 Months

    TIDieR checklist-patient

  189. In the experimental group: conformity to TIDieR checklist in each patient

    Time frame: 3 years

    TIDieR checklist-patient

  190. In the experimental group: conformity to TIDieR checklist in each center

    Time frame: Annually until end of study (5 years)

    Customized TIDieR checklist-center

  191. Satisfaction of patients and their families

    Time frame: 1 year

    Client Satisfaction Questionnaire (CSQ)-8

  192. Satisfaction of patients and their families

    Time frame: 2 years

    Client Satisfaction Questionnaire (CSQ)-8

  193. Satisfaction of patients and their families

    Time frame: 3 years

    Client Satisfaction Questionnaire (CSQ)-8

  194. Satisfaction of participants receiving help from a health coordinator

    Time frame: End of follow-up (3 years)

    7-item custom questionnaire with free answer section

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Schandrin

CONTACT

[email protected]

04.66.68.34.26

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

Acronym: PEPsy-CM

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 11, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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