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临床试验/NCT06176495
NCT06176495尚未招募不适用

Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages

American University of Beirut Medical Center0 个研究点目标入组 200 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention.

研究概览

简要总结

This is a Randomized Control Trial aiming at investigating the feasibility and effectiveness of a WhatsApp-based informative intervention on Diabetes Mellitus care in Lebanon and exploring the impact of this intervention on various aspects of Diabetes management and patient outcomes.

Family member caregivers will be also included in this interventional study as the research investigators opt to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.

详细描述

Participants with diabetes will be equally and randomly divided into an intervention group (patients with diabetes and their designated family member) of individualized WhatsApp groups which will include each participant individually and the study coordinator to protect their privacy; regular, 4-5 diabetes educational messages a week for a total of 12 weeks will be sent by noon (around 12 pm) to the intervention group participants. The other group, control group, will receive no text messages throughout this period. After 3 months, participants of the intervention group (patients with diabetes and their family members) will be asked to fill in a postintervention knowledge and practices questionnaire to delineate any marked differences in the context of knowledge and health behaviors. All participants with diabetes of both groups will be asked to recheck the previously noted clinical and laboratory parameters at 12 weeks to evaluate for any changes particularly among the intervention group who will also be asked to fill out a postintervention survey. After 6 months, all patients with diabetes will be asked to recheck their clinical and laboratory values again and members of the intervention group will be asked to fill in the practices section questionnaire again.

This research will additionally include Family Members of patients with diabetes who are involved in their care (cooking, aiding in management, securing/delivering medications, etc.). Family Member Caregivers of participants will be designated/noted by the participants who have diabetes themselves, and they will be included in the study based on their willingness to take part of the study. They will also be sorted into either a control or an intervention group in accordance with which group their relative with diabetes was sorted into, for example, if the patient with diabetes will be designated to be a part of the intervention group, this means that the family member caregiver participant will also be allocated to the intervention group. Our aim is to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.

One point to note as well is that to ensure equality among groups and for the benefit of the control group participants, the research investigators will be sharing with them the content of the text messages originally shared with the participants of the intervention group by the End of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention.

时间窗: at 3 and 6 months interval

To determine the effectiveness of diabetes tailored text messages on glycemic control in patients with diabetes mellitus, Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention will be assessed.

次要结局

  • Change in knowledge before and after the intervention (in percentage)(at 3 and 6 months interval)
  • Changes in Daily Health Practices pre and post intervention (in percentage)(at 3 and 6 months interval)
  • Assessment of Changes in Depression Screening score (in percentage pre and post intervention)(At 3 and 6 months interval)
  • Percentage change in weight (in Kg), height (in meters) and BMI (Kg/m2) pre and post intervention(At 3 and 6 months interval)
  • Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes(At 3 and 6 months interval)
  • Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention(At 3 and 6 months interval)
  • Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention(At 3 and 6 months interval)
  • Assessment of Changes in Anxiety Screening score (in percentage pre and post intervention)(At 3 and 6 months interval)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Najla El Lakkis

Specialist in Family Medicine; Specialist in Occupational Medicine; Clinical Associate in Family Medicine

American University of Beirut Medical Center

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