Hypertension Clinical Trial
| Verified date | December 2018 |
| Source | Alameda County Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether health coaching initiated in the emergency department (ED) reduces subsequent ED visits, increases primary care visits, and positively impacts health outcomes in patients with diabetes and/or hypertension.
| Status | Completed |
| Enrollment | 295 |
| Est. completion date | December 10, 2018 |
| Est. primary completion date | December 10, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Willing to work with a health coach - Plans to reside in Alameda County for the next year - Has a reliable phone number - Speaks English or Spanish - 18 years of age or older - Meets at least one of the following three criteria: (1) Low medication adherence defined as a continuous medication gap of at least 1 month in the past year OR a new diagnosis of diabetes and/or hypertension; (2) No patient-identified primary care provider (PCP) or no visit to PCP in 1 year; (3) One or more visits to the ED in the last 6 months. Exclusion Criteria: - Life-expectancy less than 1 year - Poorly controlled psychiatric illness - Homeless - Active and frequent use of illicit substances - Currently incarcerated - Already enrolled in a program for patients with high rates of hospitalization and/or emergency department visits - Unable to consent due to an unstable condition or serious emotional or neurologic condition - Admitted or anticipated to be admitted to the hospital from the ED |
| Country | Name | City | State |
|---|---|---|---|
| United States | Highland Hospital - Alameda Health System | Oakland | California |
| Lead Sponsor | Collaborator |
|---|---|
| Alameda County Medical Center | Robert Wood Johnson Foundation, University of California, Berkeley |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of emergency department visits | Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months. | 6 month period after enrollment | |
| Secondary | Number of primary care visits | Self-reported measure collected by follow-up phone surveys at 1,3, and 6 months. | 6 month period after enrollment | |
| Secondary | Physical health and mental health (Validated measure - SF-12v2) | Validated measure (SF-12v2) collected at baseline and follow-up phone surveys. | Baseline, 1 month, 3 months, and 6 months after enrollment | |
| Secondary | Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8) | Validated measure (Morisky Medication Adherence Scale, MMAS-8) collected at baseline and follow-up phone surveys. | Baseline, 1 month, 3 months, and 6 months after enrollment | |
| Secondary | Patient activation (Validated measure - Patient Activation Measure, PAM) | Validated measure (Patient Activation Measure, PAM) collected at baseline and follow-up phone surveys. | Baseline, 1 month, 3 months, and 6 months after enrollment | |
| Secondary | Type and frequency of health coach contact | Health coach documentation notes will be analyzed to determine the average percent of each type of contact (text, phone, or in-person) and frequency of contact. | 6 months after enrollment | |
| Secondary | Percent of action plan goals achieved (Health coach documentation notes) | Health coach documentation notes will be analyzed to determine the percent of goals achieved during the intervention. | 6 months after enrollment | |
| Secondary | Qualitative analysis of action plans (Health coach documentation notes will be analyzed, data will be coded to identify themes such as type of goals, barriers to care, and resources identified in the action plan) | Health coach documentation notes will be analyzed using a grounded theory approach, where transcribed data will be coded to identify themes such as type of goals, barriers to care, and resources identified in the action plan. | 6 months after enrollment |
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