Effect of medication therapy management services on clinical, humanistic, and treatment outcomes in tuberculosis patients with type 2 diabetes mellitus: an open-label randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- All seven clinical outcomes—the rate of readmission, emergency department visits, mortality rate,
研究概览
简要总结
Title of the project: Effect of medication therapy management services on clinical, humanistic and treatment outcomes in tuberculosis patients with type 2 diabetes mellitus: an open label randomized controlled study
Type of Study: Open-label Randomized controlled trial
Aims & objectives :
Primary objective:
To investigate the effect of Medication therapy management (MTM) services on clinical, humanistic and treatment outcomes in tuberculosis (TB) patients with type 2 diabetes mellitus(T2DM)
Secondary objectives:
To investigate the effect of MTM services on knowledge, attitude and practice (KAP) in TB with T2DM patients
To develop and validate a disease specific questionnaire pertaining to the quality of life in patients with TB and T2DM
In this study we are investigating whether providing the medication therapy management services along with the standard of treatment can improve the patients clinical, humanistic and treatment outcomes in TB with T2DM patients.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients ≥18 years of both gender
- •Newly diagnosed Tuberculosis patients (Pulmonary TB, Extra-pulmonary TB) with Type 2 diabetes mellitus
- •Patients receiving standard treatment regimens for TB and T2DM
- •Patients willing to participate in the study
- •Patients who are able to communicate effectively and who are conscious.
排除标准
- •TB relapse or treatment failure patients
- •Patients who refuse to take part in the study
- •Pregnant or lactating women
- •The participants lost to follow-up after discharge, will be excluded.
结局指标
主要结局
All seven clinical outcomes—the rate of readmission, emergency department visits, mortality rate,
时间窗: After one year of the patient recruitment
adverse drug events , hospital length of stay , drug-related problems , survival
时间窗: After one year of the patient recruitment
time —will be analyzed.
时间窗: After one year of the patient recruitment
Humanistic outcomes: It includes medication adherence.
时间窗: After one year of the patient recruitment
Treatment outcomes: Treatment completed, cured, treatment failed, died, lost to follow up, not
时间窗: After one year of the patient recruitment
evaluated, treatment success, prevention of recurrence of TB (patient will be followed up till 1
时间窗: After one year of the patient recruitment
year) and drug resistance.
时间窗: After one year of the patient recruitment
次要结局
- Knowledge, attitude and practice of patients towards self-management of disease.
- Health related quality of life in TB with T2DM patients.(After one year of the patient recruitment)
研究者
Dr Sonal Sekhar M
Manipal Academy of Higher Education