Table 3.
Summary of measures and timing of administration for exploratory analgesic dietary intervention for chronic daily headache as of May 2010
| Variable or Instrument | Usual Care - UC Weeks 0 to 6 |
UC + Diet Weeks 6 to 18 |
|---|---|---|
| Primary outcome | ||
| Headache QOL - HIT-6 § | Week 0, Week 6 | Week 18 |
| Secondary outcomes | ||
| Headache Diary: Frequency | Daily | Daily |
| Perceived clinical change | Week 0, Week 6 | Week 18 |
| Headache disability - MIDAS# | Week 6 | Week 18 |
| Headache Diary: Intensity/Duration | Daily | Daily |
| Headache Diary: Sleep Duration | Daily | Daily |
| Headache Diary: Medication Use/Cost | Daily | Daily |
| Headache Diary: Health care visits | Daily | Daily |
| Satisfaction with care | Week 0, Week 6 | Week 18 |
| Psychological health: BSI-18 | Week 0, Week 6 | Week 18 |
| Health status: Rand SF-12 | Week 0, Week 6 | Week 18 |
| Process measures | ||
| Nutritional and Metabolic Biomarkers | Week 6 | Weeks 10, 14, and 18 |
| Dietary Intake Assessment | Week 5-6 | Week 16-18 |
| Food Intake Diary | 3 days every 4 weeks | |
| BMI, BP, Weight | Week 5-6 | Weeks 10, 14, and 18 |
| Effect modification measures | ||
| Demographics | Week 0 | |
| Clinical Characteristics | Week 0 | |
| Expectation of benefit† | After dietary instruction | |
*International Classification of Headache Disorders, defined by expert members of the International Headache Society
† Based on a measure developed by Borkovec and Nau to measure credibility of psychological interventions.
§ Headache Impact Test was developed to measure headache-related quality of life.
# Migraine disability assessment score assesses the number of days of missed work or school in the past 3 months.