Diarrhea.Zinc10NCT02044107
The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala
A study testing Co-packaging and counseling messages in people with Diarrhea. and Pneumonia., run by Center for Studies of Sensory Impairment, Aging and Metabolism at 1 site in Guatemala.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea., Pneumonia.
- What is being tested?
- Co-packaging and counseling messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteGuatemala
- Study dates
- Feb 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Unwillingness to sign consent form.
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
Guatemala: Ministry of Public Health and Social Assistance
San Marcos, Departamento de San Marcos, 012001
Marieke Vossenaar, PhD, 50259000045, mvossenaar@hotmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Please note that the study protocol is also available in Spanish.
- Conditions
- Diarrhea., Pneumonia.
- Being tested
- Co-packaging and counseling messages
- Keywords
- Diarrhea,, Pneumonia,, Zinc treatment,, Patient Compliance.
- Medical subject headings
- Diarrhea, Pneumonia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-packaging and counseling messagesBehavioural
Also called The physical co-packaging is called the "bolsita salva-vida"
The intervention involves co-packaging in 2 distinct packages: 1) for diarrhea treatment to package zinc \& ORS for the treatment of diarrhea using a plastic bag with printed messages that were pre-tested in formative research; and 2) for pneumonia treatment to co-package zinc \& antibiotics in a plastic bag with printed messages that were pre-tested in a formative research phase. Pre-tested zinc treatment messages will be on posters displayed in the intervention health centers. Orientation will be provided to health facility staff in control and intervention areas.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Co-packaging and counseling messages |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of caregivers who administer zinc to child for at least 8 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.
Measured: 10 days
Percentage of caregivers who report giving zinc to child for at least 8 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.
Measured: 10 days
Secondary outcomes (1)
Improved Provision of Care for Treatment of Diarrhea and Pneumonia
Percentage of caregivers who receive zinc from the health post. Percentage of caregivers that reported receiving instructions on how to prepare zinc.
Percentage of caregivers that report favorable experience with treatment from the health center.
Percentage of caregivers that report favorable experience with packaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Studies of Sensory Impairment, Aging and Metabolism
- Sponsor type
- University, hospital or other
- Collaborators
- Micronutrient Initiative
- Responsible party
- Principal investigator, Marieke Vossenaar, Center for Studies of Sensory Impairment, Aging and Metabolism
- Investigators
- Marion Roche, PhD, Study director, Micronutrient InitiativeMaría del Rosario García Meza, MA, Principal investigator, Center for Studies of Sensory Impairment, Aging and MetabolismNoel W Solomons, MD, Study chair, Center for Studies of Sensory Impairment, Aging and MetabolismMarieke Vossenaar, PhD, Principal investigator, Center for Studies of Sensory Impairment, Aging and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044107
- Sponsor's protocol ID
- CeSSIAM_01
- Acronym
- Zinc10
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02044107
- Acronym / sponsor ID
- Zinc10 / CeSSIAM_01
- Conditions
- Diarrhea., Pneumonia.
- Keywords
- Diarrhea,, Pneumonia,, Zinc treatment,, Patient Compliance.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Center for Studies of Sensory Impairment, Aging and MetabolismUniversity, hospital or other
- Collaborators
- Micronutrient Initiative
- Study start
- Feb 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please note that the study protocol is also available in Spanish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-packaging and counseling messages | Experimental | Behavioral: Co-packaging and counseling messagesCurrent 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 |
| 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). |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwillingness to sign consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-packaging and counseling messagesAlso: The physical co-packaging is called the "bolsita salva-vida"The intervention involves co-packaging in 2 distinct packages: 1) for diarrhea treatment to package zinc \& ORS for the treatment of diarrhea using a plastic bag with printed messages that were pre-tested in formative research; and 2) for pneumonia treatment to co-package zinc \& antibiotics in a plastic bag with printed messages that were pre-tested in a formative research phase. Pre-tested zinc treatment messages will be on posters displayed in the intervention health centers. Orientation will be provided to health facility staff in control and intervention areas. | Behavioural | Co-packaging and counseling messages |
Primary outcome
Percentage of caregivers who administer zinc to child for at least 8 days.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Improved Provision of Care for Treatment of Diarrhea and Pneumonia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Roche, PhD study director
Micronutrient Initiative
María del Rosario García Meza, MA principal investigator
Center for Studies of Sensory Impairment, Aging and Metabolism
Noel W Solomons, MD study chair
Center for Studies of Sensory Impairment, Aging and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-packaging and counseling messages in people with Diarrhea. and Pneumonia., run by Center for Studies of Sensory Impairment, Aging and Metabolism at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marieke Vossenaar, phD (50259000045, mvossenaar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of caregivers who administer zinc to child for at least 8 days. (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.