Effect of text message reminders on treatment retention rates among outpatients with first episode psychosis: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Text message reminder intervention increases the time to dropout among patients with first episode psychosis compared to treatment as usual
研究概览
简要总结
Eligible patients satisfying inclusion criteria will be consented for study purposes. Since this is a pilot RCT, sample size has not been calculated as it is difficult to predict the dropout rates and patients will be recruited till the end of the study period. After baseline assessment, the participants will be randomly assigned into the control and intervention groups. SMS reminders for treatment appointment and medication adherence, at a frequency described before, will be sent to the intervention group. Outcome measures such as time to drop out (primary outcome) will be assessed over the follow-up period of 6 months, along with medication adherence, functioning, and insight (secondary outcomes) at 1,3 and 6 months. For the statistical analysis, survival analysis using cox proportional hazards regression will be done with group assignment as the primary variable of interest and the following as co-variates, subject to there being at least 10 events per independent variable:
1. Distance from hospital
2. Living with parents
3. Regular employment
4. Baseline psychopathology
5. Insight
6. Substance use
7. Family emergencies
8. Education
9. Age
10. Sex
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group 18 to 40 years presenting to JIPMER with first episode of psychosis with duration of illness less than 12 months and less than four weeks of treatment with antipsychotic, antidepressant, or mood stabilizer regardless of recovery.
排除标准
- •Caregivers without access to mobile phones
- •Caregivers who cannot read Tamil or english
- •Patients with organic psychosis
- •Psychosis due to substance use 5.
结局指标
主要结局
Text message reminder intervention increases the time to dropout among patients with first episode psychosis compared to treatment as usual
时间窗: 6 MONTHS
次要结局
- Medication adherence, insight, social and occupational functioning(Baseline,1, 3 and 6 months)
研究者
Dr Vikas Menon
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)