跳至主要内容
临床试验/CTRI/2024/04/066463
CTRI/2024/04/066463进行中(未招募)不适用

A study on factors associated with psychotropic medication non-adherence among persons with severe mental illness experiencing relapse and necessitating inpatient care at a tertiary psychiatric center

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
BPRS scale will be used to assess baseline severity of psychopathology following which SOFIA scale will be applied to assess reason for medication nonadherence.

研究概览

简要总结

Non-adherence to psychotropic medication is a deeply concerning issue that leads to the worsening of psychopathology, frequent relapse necessitating re-hospitalization, and a barrier in the transition of individuals with severe mental disorders to their pre-morbid selves. Although Adherence is an individual behavior it is not the responsibility of the patient alone and factors affecting non-adherence need to be analyzed thoroughly. There is a paucity of studies evaluating factors associated with non-adherence comprehensively among patients having a relapse and requiring inpatient care, especially in the Indian population. Hence this motivates the current study which aims to examine the factors associated with medication non-adherence among patients with severe mental illness resulting in relapse requiring inpatient care.

This will be prospective cross-sectional hospital-based study with the aim to identify the factors associated with medication non-adherence leading to relapse of psychopathology requiring hospitalization.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants above the age of 18 years
  • The participant has been admitted with relapse or exacerbation of an illness.
  • Medication non-adherence – Individuals who have completely stopped their therapeutic medications (antipsychotics, antidepressants, and mood stabilizers) for more than or equal to one week since requiring inpatient care.
  • Participants/family caregivers providing informed consent.

排除标准

  • Patients experiencing relapse of symptoms due to factors other than non-adherence e.g., first episode of severe mental illness, break through episode or is strictly due to substance use.

结局指标

主要结局

BPRS scale will be used to assess baseline severity of psychopathology following which SOFIA scale will be applied to assess reason for medication nonadherence.

时间窗: No intermediate time points in this trial. | Data and outcome will be assessed after completion of interviewing 150 patients. After the complete data is available estimated after 1 year - data/outcome it will be assessed

OUTCOMES

时间窗: No intermediate time points in this trial. | Data and outcome will be assessed after completion of interviewing 150 patients. After the complete data is available estimated after 1 year - data/outcome it will be assessed

To assess the factors associated with non-adherence to psychotropic medication.

时间窗: No intermediate time points in this trial. | Data and outcome will be assessed after completion of interviewing 150 patients. After the complete data is available estimated after 1 year - data/outcome it will be assessed

To assess if a specific disorder or class of psychotropic medication is disproportionately high in association with non-adherence.

时间窗: No intermediate time points in this trial. | Data and outcome will be assessed after completion of interviewing 150 patients. After the complete data is available estimated after 1 year - data/outcome it will be assessed

次要结局

  • To assess if a specific disorder or class of psychotropic medication is disproportionately high in association with non-adherence.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shah Daivik Rupeshkumar

National Institute of Mental Health And Neurosciences

研究点 (1)

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