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Impact of Peer Education Program on Headache Disorders

Primary Purpose

Headache Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community education programs
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    community support program

    Outcomes

    Primary Outcome Measures

    Reduction in number of days per month with headache after 12 months

    Secondary Outcome Measures

    Reduction in number of days per month of over the counter drugs after 12 months

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    February 8, 2016
    Sponsor
    NMP Medical Research Institute
    Collaborators
    Kaithal Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02677935
    Brief Title
    Impact of Peer Education Program on Headache Disorders
    Official Title
    Impact of Peer Education Program on Headache Disorders in Rural Communities, India: a Quasi-experimental Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NMP Medical Research Institute
    Collaborators
    Kaithal Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Headache Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    community support program
    Intervention Type
    Other
    Intervention Name(s)
    Community education programs
    Primary Outcome Measure Information:
    Title
    Reduction in number of days per month with headache after 12 months
    Time Frame
    From baseline to 12 months
    Secondary Outcome Measure Information:
    Title
    Reduction in number of days per month of over the counter drugs after 12 months
    Time Frame
    From Baseline to 12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deepa Rani
    Organizational Affiliation
    NMP Medical Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Neeraj Kumar
    Organizational Affiliation
    Kaithal Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ram Sharma
    Organizational Affiliation
    NMP Medical Research Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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