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临床试验/NCT02044107
NCT02044107Unknown不适用

Measuring the Effectiveness of Co-packaging to Improve Provider and Caregiver Behavior in the Treatment of Diarrhea With Zinc & ORS and Pneumonia With Zinc & Antibiotics for Children Under 5 Yrs From San Marcos, Guatemala

Center for Studies of Sensory Impairment, Aging and Metabolism2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
2
主要终点
Percentage of caregivers who administer zinc to child for at least 8 days.

研究概览

简要总结

This project applies a randomized community design to test the effectiveness of health center level co-packaging and counseling messages to improve provider and caregiver behavior in the treatment of diarrhea with zinc & oral rehydration salts (ORS) and treatment of pneumonia with zinc & antibiotics in children aged 2-59 mo old. We will evaluate the adherence of caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health center level co-packaging and counseling messages in addition to current standard care, by comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned to the receive only the current standard of care. Cost-effectiveness of co-packaging at the health-center level, as a means of improving provider treatment and counseling practices and caregiver adherence, will be evaluated.

The main objective is to establish the effectiveness of a facility level co-packaging and counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated in public health posts.

Specific Quantitative Objectives:

• To determine if visible co-packaging with pre-tested counseling messages:

  • Improves adherence of caregivers of children towards the prescribed zinc treatment.
  • Improves knowledge, awareness or attitudes of caregivers of children and health providers at public health care centers towards the prescribed zinc treatment.
  • Results in overall increase in health care-seeking for the treatment of diarrhea and pneumonia at public health care centers.

Specific Qualitative Objectives:

  • To establish the perception, attitudes and experiences of caregivers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.
  • To establish the perception, attitudes and experiences of health providers at public health care centers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.
  • To establish the perception, attitudes and experiences of children aged 4 to 5 years old towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.

详细描述

Please note that the study protocol is also available in Spanish.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The child is aged between between 2 and 59 mo old (< 5 years old).
  • The child is diagnosed with diarrhea or pneumonia at one of the selected public health care centers.
  • The caregiver accompanying the child to the public health care centers must live in the same household.

排除标准

  • Unwillingness to sign consent form.

研究组 & 干预措施

Co-packaging and counseling messages

Experimental

Current standard care at public health center ( zinc ORS for treatment of diarrhea and antibiotics for treatment of of pneumonia).

The intervention consists of health center level co-packaging and visual counseling messages (zinc & ORS packaged at health center for diarrhea, and zinc & antibiotics co-packaged at health center for pneumonia) Co-packaging is done in a plastic bag, which is covered with pre-tested zinc treatment messages - a distinct packaging has been designed for diarrhea and for pneumonia

干预措施: Co-packaging and counseling messages (Behavioral)

Control group

No Intervention

Current standard care at public health center (zinc & ORS for treatment of diarrhea and zinc & antibiotics for treatment of of pneumonia).

结局指标

主要结局

Percentage of caregivers who administer zinc to child for at least 8 days.

时间窗: 10 days

Improved adherence to diarrhea or pneumonia treatment with zinc for the prescribed 10 days based on pill count in the home. Expressed as percentage of caregivers who administer zinc to child for at least 8 days.

Percentage of caregivers who report giving zinc to child for at least 8 days.

时间窗: 10 days

Improved adherence to diarrhea or pneumonia treatment with zinc for the prescribed 10 days based on self-reports. Expressed as percentage of caregivers who report administering zinc to child for at least 8 days.

次要结局

  • Improved Provision of Care for Treatment of Diarrhea and Pneumonia(6 months)

研究者

发起方
Center for Studies of Sensory Impairment, Aging and Metabolism
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marieke Vossenaar

Senior Program Leader for Diet and Health

Center for Studies of Sensory Impairment, Aging and Metabolism

研究点 (2)

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