EFFECTIVENESS OF INDIVIDUAL BASED LIFESTYLE MODIFICATION VERSUS TEHNO-BASED LIFESTYLE MODIFICATION INTERVENTION ON SELF-CARE, GLYCEMIC CONTROL, FOOT ULCER RISK AND QUALITY OF LIFE OF PATIENTS WITH DIABETES MELLITUS- A RANDOMIZED CONTROLLED TRIAL.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Self-care practices assessed through the Diabetes Self-Management Questionnaire-Revised.
研究概览
简要总结
OBJECTIVESPrimary objective:1.To determine the effectiveness of individual based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.2. To evaluate the effectiveness of techno-based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.3.To compare the effectiveness of individual based lifestyle modification intervention versus Techno-based lifestyle modification intervention on self-care compliance and glycemic control of patients with type 2 Diabetes mellitus.Secondary objective:1.To compare the effectiveness of individual based lifestyle modification versus techno-based lifestyle modification intervention on foot ulcer risk and Quality of Life of patients with type 2 Diabetes mellitus.2.To find out the association between socio demographic, clinical variable with self-care, glycemic control, foot ulcer risk and Quality of Life.
HYPOTHESES
H 1: There will be a significant difference in self-care, glycemic control, foot ulcer risk and quality of life among the patients with type 2 Diabetes mellitus who receive individual based lifestyle modification intervention and those who receive standard care at (P<0.05).
H2. There will be a significant difference in self-care and glycemic control, foot ulcer risk and quality of life among the patients with type 2 Diabetes mellitus who received techno-based lifestyle modification intervention and those who receive standard care at (P<0.05).
H 3: There will be a significant difference in self-care, glycemic control, foot ulcer risk and quality of life of patients with type 2 Diabetes mellitus who receive individual based lifestyle modification intervention and those who receive techno-based lifestyle modification intervention at (P<0.05).
Plan for Data CollectionFormal permission will be obtained from Chairperson, Ethical committee. Patient information sheet will be obtained and informed consent will be obtained. Demographic and clinical data will be extracted from medical records. In study period the individual based and techno-based life style modification intervention will be administered to Experimental Group A and Experimental Group B for 6 months. For Individual based life style modification intervention group, the patients will be assessed using medical history, current medications, lifestyle factors, psychosocial factors and cultural considerations and educated about the monitoring of blood glucose levels, medication adherence, insulin regimens, maintaining of balanced diet, engaging in regular physical activity, foot care and the diabetes complications.Along with the education, the demonstration will be done regarding the foot care and self- administration of insulin. The counselling session will be conducted twice in the first month of the study period and once in a month in the consequent months.For the Techno-based life style modification intervention group, a DM app will be developed to monitor the glycemic control, self-care, foot ulcer risk and Quality of Life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are diagnosed with Type 2 Diabetes mellitus and with HbA1c 8% and above 8%.
- •Patients who aged 40-70 yrs.
- •Both male and female.
- •Patients who can use android mobile phones with ease.
- •Patients who could read and understand Tamil or English.
排除标准
- •Patients with severe complications like retinopathy, neuropathy, nephropathy.
- •Patients with peripheral vascular disease, eczema and injury or trauma to foot.
- •Patients diagnosed with psychiatry illness.
- •Patients diagnosed with cognitive or visual disturbances.
结局指标
主要结局
Self-care practices assessed through the Diabetes Self-Management Questionnaire-Revised.
时间窗: 1st month | 3rd month | 6th month
Self-care, Blood Sugar and HbA1C.
时间窗: 1st month | 3rd month | 6th month
Self-care, Blood Sugar, HbA1C, Foot Ulcer risk assessment through the Diabetic foot risk assessment tool-Knowledge assessment tool, Diabetes Foot care Questionnaire and SINBAD and Quality of Life assessment through the WHOQOL- BREF 26 Item Questionnaire.
时间窗: 1st month | 3rd month | 6th month
次要结局
- QUALITY OF LIFE(Post Test 3- 6 months – Self-care, Glycemic control, Foot ulcer risk & Quality of life)
研究者
JV JEEVITHA
KMCH COLLEGE OF NURSING