Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 12
- 主要终点
- change in body mass index (BMI)
研究概览
简要总结
Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.
Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.
Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.
Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject over 15 years of age
- •Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
- •Included after a first inpatient hospitalization in specialized care
- •Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
- •With medical insurance
- •Can be reached by telephone
排除标准
- •Uncompensated psychiatric pathology
- •Refusal to participate in the study
- •The inability to consent to care (patient or his/her legal representative)
- •Pregnancy
- •Major incapable subject or under guardianship or judicial protection
- •Homelessness
- •No mastery of reading and writing
研究组 & 干预措施
eatline group
干预措施: Eatline (Other)
control group
干预措施: Control (Other)
结局指标
主要结局
change in body mass index (BMI)
时间窗: from discharge of the first hospitalization to 12 months.
次要结局
- The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)(at baseline, at 6 months , at 1 year)
- Mini International Neuropsychiatric Interview (MINI)(at baseline, at 6 months , at 1 year)
- SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)(at baseline, at 6 months , at 1 year)
- Rate of patients lost to follow-up visits(during the one year)
- Rate of patients with at least one re-hospitalization or earlier consultations than expected(during the one year)
- change in BMI from the first hospitalization(from the first hospitalization to 6 months and at 1 year)
- Medico-economic evaluation with the MEDEC questionnaire(at 6 months, at 1 year)
- The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)(at baseline, at 6 months , at 1 year)
- The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)(at baseline, at 6 months , at 1 year)