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临床试验/CTRI/2025/04/085870
CTRI/2025/04/085870尚未招募不适用

Effect of Center and Voice call based Diabetic Self Management Coaching(CV-DSMC) on clinical and behavioral outcome among elderly people with type 2 diabetes at KMCH RHTC Vagarayampalayam coimbatore India

MALARKODI M1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年5月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
HbA1c

研究概览

简要总结

INTERVENTIONCentre and Voice call based   (CV –DSMC) Diabetes Self-Management Coaching

The  intervention will be delivered in two phases

Phase  I- Centre based Coaching

Phase II- Voice call Coaching

Centre based coaching  is categorized into 2 types :1) Educational, which refers to interventions in which patients with diabetes mellitus primarily receive information from the researcher, focusing on the provision of information to improve patients’ knowledge of diabetes self-management.Face to face  education will be imparted by the researcher through a prerecorded laptop assisted lecture and discussion method using visual aids like charts and pamphlet  in group sessions of four hours, split in to four  teaching sessions of 30 minutes each. A total of 20 groups with 6 to 7 patients in each group  will be grouped for the education sessions. The content of the education includes diabetes mellitus, short term and life-threatening complications of diabetes, long term concerns, other health issues of diabetes mellitus, principles of diabetes management self-care in diabetes mellitus, planning diet and the way forward.

Educational  intervention total 2 hrs( 1/2 hr/session- 4 weeks)

  1. Behavioral, which refers to the interventions targeting improved self-management behaviors, with a focus on active skills training and emphasizing change in skills and/or lifestyle associated with the implementation of a diabetes self-management regimen, such as diet, physical activity, blood glucose monitoring, adherence to medication and application of virgin coconut oil. Foot care ,foot ankle exercise and foot massage will be demonstrated The samples   will be asked to do return demonstration and correction will be given on timely manner

Behavioural intervention & Demonstration -total 2 hrs (1/2 hr/session- 4 weeks)

Reinforcement-I( 1 hr/week-   8 week   Reinforcement-II (1 hr/week  -8 weeks)

Post test I at  6months

 Phase II- Voice call Coaching

The participants  will be offered 10- to 20-min voice call coaching sessions will be bimonthly for four sessions within first 2 months and  two sessions within last 2 months. The coach ask each patient to create one specific behavior goal related to physical activity, healthy diet, medical adherence, and/or regular blood glucose monitoring to be addressed during the first 3 months of the study. If a patient have more than one behavior change target, the coach will ask he or she  to prioritize the goals and then, together, they address  one subject per coaching session. At the end of each coaching session, the coachee need to discuss the time, and agenda of the next coaching call with the coach. During each voice call coaching session, the participant is reviewed his or her work in the previous 2 weeks with respect to the self-selected behavior goal and action plan, and then create a new goal or modify  existing goals. If a goal is not achieved, the coach help the participant identify and make a plan for overcoming barriers to achieving the goal. Post test I and II will be carried out after  6 months and  10months respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with type 2 diabetes with a duration of 5 years 2.Patients with HbA1c more than 8
  • Aged between 60-80 years and Patients of both sex 4.Patient with symptoms of neuropathy with confirmed type 2diabetes 5.An average daily Neuropathy pain score more than4.

排除标准

  • Patients who are having Plantar ulcers and foot problems 2.Patients with hearing deficit 3.History of Orthopedics complications 4.Patients with chronic kidney disease 5.Patients with other skin disease.

结局指标

主要结局

HbA1c

时间窗: 6month and 9 months

次要结局

  • compliance to treatment(9 months)

研究者

发起方
MALARKODI M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MALARKODI M

KMCH COLLEGE OF NURSING

研究点 (1)

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