Impact of Peer Education Program on Headache Disorders | NCT02677935

Studies
Impact of Peer Education Program on Headache Disorders

NCT02677935

Sponsor

NMP Medical Research Institute

Status

Completed

Last Update Posted

Feb 9, 2016Estimated

Enrollment

360Actual

Phase

Not Applicable

Conditions

Headache Disorder

Interventions

Community education programs

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2016

Last Update Posted Date

Feb 9, 2016Estimated

Name	Class
Kaithal Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	community support program	Other: Community education programs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Community education programs	Other		Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in number of days per month with headache after 12 months		From baseline to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in number of days per month of over the counter drugs after 12 months		From Baseline to 12 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All residents of the Region Kaithal (haryana) may apply for recruitment
Primary headache disorders including tension type headache, migraine

Exclusion Criteria:

Planning to move the area
Refused to consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepa Rani	NMP Medical Research Institute	Principal Investigator
Neeraj Kumar	Kaithal Hospital	Principal Investigator
Ram Sharma	NMP Medical Research Institute	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020773	Headache Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided