跳至主要内容
临床试验/CTRI/2024/01/062161
CTRI/2024/01/062161招募中不适用

Factors affecting medication adherence in bipolar disorder in a tertiary care hospital: a cross-sectional observational study

Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
To assess the proportion of bipolar disorder patients adherent to their prescribed medication

研究概览

简要总结

OBJECTIVES OF PROPOSED RESEARCH:

Primary objective:

·       To assess the proportion of bipolar disorder patients adherent to their prescribed medication

·       To assess the factors influencing adherence to medication among these patients

 Secondary objective:

 Â·       To assess the attitudes of bipolar disorder patients about psychiatric medications

·       To assess the quality of life among these patients

·       To assess the need of counselling among these patients

 BACKGROUND OF THE STUDY: Non-adherence in patients with bipolar disorder results in aggravation, bipolar disorder recurrence, emergency room visits, hospitalization, and poor psychosocial outcomes . Though non-adherence rates have been reported to range between 30-50% in patients with bipolar disorder , the problem of adherence is often either overlooked by the physician or denied by the patient. An essential first step to enhancing medication adherence is to objectively estimate adherence.

METHODOLOGY: Bipolar disorder patients (diagnosed by ICD-10 criteria) under stable prescribed dose of medicines for 6 months and in clinical remission from the outpatient department will be recruited as per selection criteria.  Patients will be assessed using the following scales:

  • Morisky Medication Adherence Scale (MMAS)-8
  • Young Mania Rating Scale (YMRS)
  • WHO Quality of Life – BREF
  • Drug Attitudes Inventory (DAI)-10

 EXPECTED OUTCOME: Possible factors behind poor adherence identified in the study may assist in better understanding of patient behaviour regarding medication intake and suggest ways to improve therapeutic outcome in the long run.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed bipolar disorder patients as per ICD-10 criteria and under stable prescribed dose of medicines for the last 6 months and in clinical remission at the time of assessment.

排除标准

  • Any acute illness likely to influence medication adherence Patients in acute manic or depressed phase Patients with other significant comorbidities including substance abuse except caffeine and nicotine.

结局指标

主要结局

To assess the proportion of bipolar disorder patients adherent to their prescribed medication

时间窗: 1 year 6 months

To assess the factors influencing adherence to medication among these patients

时间窗: 1 year 6 months

次要结局

  • To assess the attitudes of bipolar disorder patients about psychiatric medications(To assess the quality of life among bipolar disorder patients)

研究者

发起方
Institute of Postgraduate Medical Education and Research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nadeem Chowdhury

Institute of Post Graduate Medical Education and Research

研究点 (1)

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