Evaluating the Efficacy of MITRA-C Mobile Application Based Intervention in Improving Treatment Outcomes among Patients with Schizophrenia – A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Medication Adherence Rates: Via questionnaires
研究概览
简要总结
Objective
The primary aim of this study is to assess the effectiveness of MITRA-C, a mobile-based intervention for treatment adherence in chronic mental illness schizophrenia, in improving treatment adherence and overall mental health outcomes in patients with schizophrenia.
Intervention MITRA-C
MITRA-C is a mobile application designed to enhance medication adherence, monitor symptoms, and provide psychoeducation and motivational support to patients with schizophrenia.
It includes features such as medication reminders, symptom tracking, motivational content, and secure communication with healthcare providers to improve engagement with treatment.
Study Design
This is a randomized controlled trial with a parallel design, where patients are randomly assigned to either the intervention group MITRA-C or the control group which receives standard care.
Treatment outcomes will be assessed at baseline, one month, and three months, focusing on medication adherence, symptom severity, and relapse rates.
Primary Outcome
The primary outcome of the study is to measure medication adherence using objective measures such as pill counts or medication event monitoring systems, along with changes in symptom severity and relapse rates.
Significance
This study addresses a common issue in schizophrenia treatment: poor medication adherence, which can lead to relapse and hospitalization.
By utilizing a mobile-based intervention, the study aims to provide a more accessible and effective method to improve patient outcomes, with the potential to reduce relapse rates and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Schizophrenia: Participants must have a confirmed diagnosis of schizophrenia according to the DSM-5 criteria, with either acute or chronic symptoms that are stable enough to allow participation in the study (without requiring immediate hospitalization).
- •This ensures the study targets the intended population with schizophrenia.
- •Sources: Diagnostic and Statistical Manual of Mental Disorders (DSM-5), American Psychiatric Association,
- •Age Range: Participants should be aged 18 years or older but not exceeding 60 years, as the app and intervention may be more effective in adults and may not be appropriate for elderly populations with specific health complications.
- •Sources: Velligan et al., 2004; Muench & Hamer,
- •Ability to Provide Informed Consent: Participants must have the mental capacity to provide informed consent for participation in the study, ensuring they understand the nature of the intervention and their role in the research.
- •This is a standard criterion for all clinical trials.
- •Sources: Ethical guidelines for clinical research, World Health Organization (WHO).
排除标准
- •Severe Cognitive Impairment: Participants with significant cognitive impairments, such as those with a Mini-Mental State Examination (MMSE) score lower than 24 or severe executive dysfunction, should be excluded.
- •This ensures that participants can understand and use the mobile app, which may be challenging for those with severe cognitive deficits.
- •Recent Psychiatric Hospitalization or Acute Psychotic Episodes: Participants who have been hospitalized for acute psychosis or severe exacerbations of schizophrenia in the last 30 days should be excluded.
- •Acute episodes could impair their ability to engage with the study intervention effectively.
- •Severe Medical or Neurological Conditions: Participants with significant neurological disorders (e.g., severe epilepsy) or uncontrolled medical conditions (e.g., diabetes, cardiovascular disease) that could interfere with the study or treatment adherence should be excluded.
结局指标
主要结局
1.Medication Adherence Rates: Via questionnaires
时间窗: 0 weeks,8 weeks,12 weeks
2.Reduction in Relapse Rates
时间窗: 0 weeks,8 weeks,12 weeks
3.Symptom Severity
时间窗: 0 weeks,8 weeks,12 weeks
次要结局
- 1. Quality of life.(2. Engagement with App.)
研究者
Sharni Souganthi S
Saveetha medical college and hospital