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临床试验/NCT05996601
NCT05996601尚未招募不适用

Evaluation of Selected Improved Outcomes Among Patients With Diabetes and/or Hypertension in Designated Community Pharmacies in a Metropolitan City - An Intervention Study

University of Ibadan2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
2
主要终点
Blood glucose control of participants

研究概览

简要总结

The goal of this interventional study is to compare improved outcomes among diabetes and/or hypertensive patients sequel to educational intervention. The study aims to answer the following questions:

  • What are the patients' levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity?
  • Does educational intervention by pharmacists improve health outcomes of patients with diabetes and/or hypertension?
  • Are there associations between patient-related variables such as health literacy, medication adherence, disease knowledge, attitude to disease? Participants' anthropometric measurements and point-of-care testing for disease monitoring e.g., blood pressure, blood glucose would be carried out. Baseline assessment of participants would be done to evaluate their levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity.

Patients' baseline assessment would be carried out, after which they would receive educational materials and would be followed up by pharmacist. The baseline assessments would be repeated at three and six months after the intervention to measure the effectiveness of the intervention.

详细描述

The anthropometric measurements would include weight, height, waist circumference, hip circumference, from which the body mass index and waist-hip ration would be calculated.

The assessment of the disease knowledge and attitude would be done using validated semi-structured questionnaires earlier designed by the principal investigator and used among ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare facilities. The validated International Physical Activity Questionnaire (IPAQ) would be utilized for participants' physical activity assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • Minimum of 18 years of age
  • Patients must be diagnosed with diabetes and/or hypertension
  • Patients must be on at least one medication
  • Patients who access one of the selected community pharmacies for prescription refill

排除标准

  • Non-consented patients
  • Patients not based at the study site

结局指标

主要结局

Blood glucose control of participants

时间窗: 6 months

Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.

Blood pressure control

时间窗: 6 months

Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.

Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.

时间窗: 6 months

Participants weight in kilograms and height in meters would be measured at baseline, 3- and 6-month postintervention. Their body mass index would be compared to find out if there are changes.

Medication adherence of participants using a 4-item medication adherence scale

时间窗: 6 months

Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.

Participants' level of disease knowledge and attitude

时间窗: 6 months

The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.

次要结局

未报告次要终点

研究者

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

Akinniyi Akinbiyi Aje

Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)

University of Ibadan

研究点 (2)

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