Headache DisorderNCT02677935
Impact of Peer Education Program on Headache Disorders
A study testing Community education programs in people with Headache Disorder, run by NMP Medical Research Institute.
Trial summary
Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorder
- What is being tested?
- Community education programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All residents of the Region Kaithal (haryana) may apply for recruitment
- Primary headache disorders including tension type headache, migraine
Who cannot join
- Planning to move the area
- Refused to consent
About this study
Official title: Impact of Peer Education Program on Headache Disorders in Rural Communities, India: a Quasi-experimental Study
Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.
- Conditions
- Headache Disorder
- Being tested
- Community education programs
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community education programsOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | community support program Receives: Other: Community education programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of days per month with headache after 12 months
Measured: From baseline to 12 months
Secondary outcomes (1)
Reduction in number of days per month of over the counter drugs after 12 months
Measured: From Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kaithal Hospital
- Responsible party
- Sponsor
- Investigators
- Deepa Rani, Principal investigator, NMP Medical Research InstituteNeeraj Kumar, Principal investigator, Kaithal HospitalRam Sharma, Study director, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677935
- Sponsor's protocol ID
- nmp/22182
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peer Education Program on Headache Disorders in Rural Communities, India: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT02677935
- Acronym / sponsor ID
- nmp/22182
- Conditions
- Headache Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Kaithal Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Feb 2016 (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.
Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Community education programscommunity support program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All residents of the Region Kaithal (haryana) may apply for recruitment
- Primary headache disorders including tension type headache, migraine
Key exclusion criteria (2 listed)
- Planning to move the area
- Refused to consent
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 |
|---|---|---|
| Community education programs | Other | Intervention |
Primary outcome
Reduction in number of days per month with headache after 12 months
Time frame: From baseline to 12 months
1 secondary outcome
Reduction in number of days per month of over the counter drugs after 12 months
Time frame: From Baseline to 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Deepa Rani principal investigator
NMP Medical Research Institute
Neeraj Kumar principal investigator
Kaithal Hospital
Ram Sharma study director
NMP Medical Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Community education programs in people with Headache Disorder, run by NMP Medical Research Institute.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number of days per month with headache after 12 months (time frame: From baseline to 12 months). 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 9 Feb 2016.