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临床试验/NCT06064253
NCT06064253已完成不适用

Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

Zagazig University2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2023年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
2
主要终点
improved patients function and improved patient pain

研究概览

简要总结

the aim is to measure the level of adherence of knee osteoartheritis patients to a Carefully curated program that follows the American College of Rheumatology/Arthritis (ACR) recommendation guidelines and investigate the factor that might affect the patient's adherence to the prescribed protocol.

详细描述

2.3. interventional protocol (for intervention group only): For the Intervention group: A face-to-face semi-structured interview was carried out with each participant separately. The interview (30-45minuts) included a health education program explaining the nature of the condition(KOA causes, pathological changes, and natural course of the disease), we explained the recommendations for the treatment of KOA, teaching the patient a home exercise program of 5 exercises (targeting knee extensor and hip muscle ), selection of a physiotherapy program suitable to the patient clinical condition, recommendations to increase daily physical activity ( e.g. brisk walking) with joint protection measures along with a weight reduction regimen proposed in overweight and obese patients and prescribing a suitable pharmacological treatment to the patients mentioning side effect that might occur. At the end of the interview, each participant received a booklet including the recommendations for the treatment of knee osteoarthritis according to the ACR.

As for the control group, they were assigned the traditional approach for KOA management, they were told their diagnosis if they were not already familiar with it, received the treatment for KOA according to ACR guidelines, they were offered physical therapy modalities if their condition required but they were not given the health education program or the other interventional steps.

2.4. Follow-up period: Throughout the following three months after enrollment, participants were followed up every ten days; asking about persistence on the prescribed treatment and exercise program, the level of their daily activity, and their diet plan. For participants who failed to attend for any reason, a telephone call was performed to provide behavior change support in both groups. The telephone call aimed to observe adherence to treatment in the control group and to increase levels of participation in the intervention group.

研究设计

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

入排标准

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

入选标准

  • diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria

排除标准

  • Patients with a
  • A history of knee trauma or injury
  • patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis)
  • severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.

结局指标

主要结局

improved patients function and improved patient pain

时间窗: 3 MONTHS

measured by Western Ontario and McMaster University Osteoarthritis Index contains 5 items that address the following person-level activities: walking, stair climbing, sitting, lying down, and standing --measured by visual analog scale

measuring KOA patients adherence

时间窗: 3 months

adherence survey based on morsiky adherence scale

次要结局

  • investigating the factors that hinder patient adherence(3 months)

研究者

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

Amany Mohammed Ibrahim Ebaid

Associate professor

Zagazig University

研究点 (2)

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