BehaviorNCT01235247
Decision Support AMPATH
A study testing reminders vs. no reminders in people with Behavior, run by Indiana University at 1 site in Kenya.
Trial summary
Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behavior
- What is being tested?
- reminders vs. no reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteKenya
- Study dates
- Feb 2011to Mar 2012
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Martin Were, MD MS contact
Kenya1 site, 1 recruiting
- Recruiting
USAID-AMPATH Clinics
Eldoret
Allan Sudoi, +254 721821242, aksudoi@GMAIL.COM
About this study
Official title: Electronic Medical Records to Improve Patient & Public Health in Rural Kenya
Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.
Read the detailed description
The investigators will assess the effects of computer-generated reminders for the 3 cohorts of patients: (1) pregnant women; (2) HIV-exposed infants; and (3) adults and children co-infected with TB and HIV identified from the AMPATH clinics. Patients will be randomized to either receive the reminders as part of a paper summary, or to not have any of the reminders in their summary. Reminders implemented will vary by type of patient population. Comparisons will be made between the intervention and control groups.
- Conditions
- Behavior
- Being tested
- reminders vs. no reminders
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminders vs. no remindersBehavioural
Intervention providers will receive clinical reminders as part of patient care, and control group providers will not receive the reminders
| Study group | Role | What they receive |
|---|---|---|
| reminders, no reminder | Experimental | Not described Receives: Behavioral: reminders vs. no reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rates with care guidelines
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionOct 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies 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
- Health services research
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Moi Teaching and Referral Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235247
- Sponsor's protocol ID
- 0709-63
- Status last verified
- Sep 2007
- First submitted
- 4 Nov 2010
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Were MC, Nyandiko WM, Huang KT, Slaven JE, Shen C, Tierney WM, Vreeman RC. Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting. Pediatrics. 2013 Mar;131(3):e789-96. doi: 10.1542/peds.2012-2072. Epub 2013 Feb 25.
PubMed 23439898
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Medical Records to Improve Patient & Public Health in Rural Kenya
- ClinicalTrials.gov ID
- NCT01235247
- Acronym / sponsor ID
- 0709-63
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Moi Teaching and Referral Hospital
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 5 Nov 2010 (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.
Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.
Detailed description
The investigators will assess the effects of computer-generated reminders for the 3 cohorts of patients: (1) pregnant women; (2) HIV-exposed infants; and (3) adults and children co-infected with TB and HIV identified from the AMPATH clinics. Patients will be randomized to either receive the reminders as part of a paper summary, or to not have any of the reminders in their summary. Reminders implemented will vary by type of patient population. Comparisons will be made between the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reminders, no reminder | Experimental | Behavioral: reminders vs. no reminders |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| reminders vs. no remindersIntervention providers will receive clinical reminders as part of patient care, and control group providers will not receive the reminders | Behavioural | reminders, no reminder |
Primary outcome
Compliance rates with care guidelines
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Derived from this study: PubMed 23439898Were MC, Nyandiko WM, Huang KT, Slaven JE, Shen C, Tierney WM, Vreeman RC. Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting. Pediatrics. 2013 Mar;131(3):e789-96. doi: 10.1542/peds.2012-2072. Epub 2013 Feb 25.
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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.
Martin Were, MD MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reminders vs. no reminders in people with Behavior, run by Indiana University at 1 site in Kenya.
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 1 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 29 Jul 2011. 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 Kenya. 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 Martin Were, MD MS (317-423-5540), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rates with care guidelines (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235247, which also lists 1 linked publication.
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 29 Jul 2011.