N/A
Completed N=312
A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults
Asthma · Communication
Source: ClinicalTrials.gov NCT01972308 ↗
Enrolled (actual)
312
Serious AEs
57.4%
Results posted
Aug 2018
Primary outcomePrimary: Change in Asthma Control at One Year — -0.42; -0.11 units on a scale
Summary
Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control at One Year |
-0.42; -0.11 | — |
| SECONDARY Change in Emergency Department(ED) Visits at One Year |
-0.90; -0.24 | — |
| SECONDARY Change in Asthma-related Quality of Life |
0.28; 0.23 | — |
| SECONDARY Change in Hospitalizations |
-0.30; -0.36 | — |
| SECONDARY Risk of Prednisone Bursts |
-0.005; -0.05 | — |
| SECONDARY Change in Urgent Office Visit |
-0.24; -0.42 | — |
Eligibility Criteria
Inclusion Criteria
- > 18 years of age,
- physician's diagnosis of asthma,
- prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),
- moderate or severe persistent asthma according to the NHLBI Guidelines,
- evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) 15% and 200ml in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC >12% and 200 ml in FEV1 within 30 minutes,
- at least one appointment scheduled with the asthma physician during the 1st 6 months of participation
Exclusion Criteria
- Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.
- Unable to understand and provide informed consent,
- Unable to communicate in English or Spanish.
- Participants of the pilot study for this project are excluded
Data sourced from ClinicalTrials.gov (NCT01972308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.