NCT02677935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 5, 2016

Last Update Submit

February 8, 2016

Conditions

Headache Disorder

Outcome Measures

Primary Outcomes (1)

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

    From baseline to 12 months

Secondary Outcomes (1)

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

    From Baseline to 12 Months

Study Arms (1)

Intervention

EXPERIMENTAL

community support program

Other: Community education programs

Interventions

Community education programsOTHER
Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Planning to move the area
  • Refused to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Deepa Rani

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR

  • Neeraj Kumar

    Kaithal Hospital

    PRINCIPAL INVESTIGATOR

  • Ram Sharma

    NMP Medical Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share