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临床试验/CTRI/2024/06/069070
CTRI/2024/06/069070尚未招募不适用

Effect of text message reminders on treatment engagement among patients with severe mental illness after discharge from inpatient settings: A randomised controlled trial

JIPMER1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
340
试验地点
1
主要终点
Time to drop out (i.e treatment engagement) is the primary outcome over the study period of 12 months

研究概览

简要总结

This randomized controlled trial tries to find out the effect of mobile phone-based text message reminders on time to drop out from treatment among patients with severe mental illnesses after discharge from an inpatient setting across a follow-up period of 12 months from discharge. The patients will be randomly divided into two groups (intervention and standard care groups). The intervention group will receive two sets of text message reminders on their mobile phones. One set will be variable one, where they will receive a text message on the phone three days and five days before their next follow-up visit (every four weeks). The second set of fixed-frequency text message reminders will be sent for medication adherence on Monday and Thursday of every week. There will be twice weekly messages except in one week, with four messages per week. The control group will get the usual treatment during the study period (12 months) without any intervention. Both groups of patients will be assessed for time to drop out across a 12-month follow-up period and for change in medication adherence, insight and functioning at baseline, at eight weeks, six months.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of Schizophrenia, Bipolar disorder, Severe depression with psychotic symptoms admitted to inpatient department of Psychiatry, JIPMER,Puducherry
  • At least six months of duration of illness.

排除标准

  • Patients/Caregivers without access to mobile phones
  • Patients/Caregivers who cannot read Tamil/English
  • Patients with organic psychosis
  • Psychosis due to substance use 5.

结局指标

主要结局

Time to drop out (i.e treatment engagement) is the primary outcome over the study period of 12 months

时间窗: 1 week, 3rd week, 5th week, 3rd month onwards monthly till the 12th month (study end point)

次要结局

  • Six-month trends in medication adherence, insight, and functioning among inpatients with severe mental illnesses after discharge from inpatient setting in intervention versus control group(The patient will be assessed at baseline, eight weeks and six months)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Natarajan Varadharajan

JIPMER

研究点 (1)

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