Impact of an Intensive Lifestyle Intervention Program on Out of Pocket Expenditure for the Management of Type 2 Diabetes in India- A One Year Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Assess the effect of the ILI program in reducing the OOP expenditure for T2D management
研究概览
简要总结
The proposed study is a single-arm pre-post design intervention trial that aims to assess the OOP expenditure for T2D treatment in patients with T2DM enrolled in a diabetes remission program and to evaluate the effectiveness of a one-year intensive lifestyle intervention (ILI) program on OOP expenditure for T2D patients. Specific Objectives are: 1) To assess the impact of a one-year online Intensive Lifestyle Intervention (ILI) on OOP expenditure of T2D patients in India. 2) To estimate the OOP expenditure for managing type 2 diabetes. 3) To identify factors associated with OOP expenditure 4) To assess the impact of OOP expenditure on medication adherence and glycemic control. The intervention comprises lifestyle modification with a plant-based diet, exercise, psychological support, and medical management. The intervention will be 12 months (6-month intervention + 6-month follow-up). Data (socio-demographic data, disease severity, treatment regimen, healthcare utilization patterns, administration of expenditure questionnaire) will be collected at two-point times, at the baseline and end-line at the end of 12 months after the delivery of the intervention. Compliance data will be collected from patients. Adherence data will be collected from patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent.
- •Men and women aged 30-70 years.
- •Confirmed diagnosis of type 2 Diabetes- All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic anti-diabetic medications or HbA1c ≥ 48 mmol/mol (6.5%) with or without medication.
- •Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation.
- •Well-oriented in time, space & as a person.
排除标准
- •Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood).
- •Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation).
- •Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation).
- •Pregnant or lactating women.
结局指标
主要结局
1. Assess the effect of the ILI program in reducing the OOP expenditure for T2D management
时间窗: Out of expenditure will be measured at 2 time points- baseline and at the end of 12 months i.e. 52 weeks of the intervention
2. Estimate the average OOP expenditure for T2D patients.
时间窗: Out of expenditure will be measured at 2 time points- baseline and at the end of 12 months i.e. 52 weeks of the intervention
次要结局
- 1. Identify factors associated with higher OOP expenditure.(2. Evaluate the relationship between OOP expenditure, medication adherence & glycemic control.)
研究者
Dr Pramod Tripathi
Freedom From Diabetes Research Foundation