Diabetes MellitusNCT02386540
Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
A study testing Health Coaching in people with Diabetes Mellitus and Hypertension, run by Alameda County Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2015to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Highland Hospital - Alameda Health System
Oakland, California, 94602
About this study
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.
Read the detailed description
Patients will be recruited by health coaches from the Highland Hospital Emergency Department. Eligible patients who agree to participate will be randomized to the control and experimental groups in a 2:1 ratio respectively because experimental group size is limited by health coach availability and greater loss-to-follow up is expected among the control group. Repeated measures analysis will be used to compare each outcome over the study period. In addition, subgroup analyses will be performed in order to stratify by baseline survey measures or amount of ED visits in the pre-observation period.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Health Coaching
- Keywords
- Community Health Workers, Community Health Workers: utilization, Emergency Service, Primary Health Care/utilization, Health Services Accessibility
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
The Alameda County Health Coach program pairs patients with a language-concordant health coach for six months following an ED visit. Health coaches are young adults from the local community employed through Alameda County and trained for three months in topics such as self-management support and motivational interviewing. Health coaches work one-on-one with participants in order to develop an action plan in order to achieve patient-identified health goals. Communication between the health coach and participant includes text messages (weekly), phone calls (twice a month), face-to-face visits (at least once), and accompaniment to a primary care visit (at least once). Health coaches may also assist participants in accessing community resources as related to the individualized action plan.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Patients randomized to the experimental arm receive six months of post-ED health coaching from the Alameda County Health Coach Program (ACHCP) in addition to usual care in the emergency department at enrollment. Receives: Behavioral: Health Coaching |
| Usual Care | No intervention | Patients randomized to the control arm receive usual care in the emergency department at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of emergency department visits
Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months.
Measured: 6 month period after enrollment
Secondary outcomes (7)
Number of primary care visits
Self-reported measure collected by follow-up phone surveys at 1,3, and 6 months.
Measured: 6 month period after enrollment
Physical health and mental health (Validated measure - SF-12v2)
Validated measure (SF-12v2) collected at baseline and follow-up phone surveys.
Measured: Baseline, 1 month, 3 months, and 6 months after enrollment
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.
Measured: Baseline, 1 month, 3 months, and 6 months after enrollment
Patient activation (Validated measure - Patient Activation Measure, PAM)
Validated measure (Patient Activation Measure, PAM) collected at baseline and follow-up phone surveys.
Measured: Baseline, 1 month, 3 months, and 6 months after enrollment
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.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start6 Feb 2015
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alameda County Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Harrison J. Alter, Alameda County Medical Center
- Investigators
- Jocelyn Freeman-Garrick, MD, Principal investigator, Highland Hospital - Alameda Health SystemBerenice Perez, MD, Principal investigator, Highland Hospital - Alameda Health SystemHarrison Alter, MD, Principal investigator, Highland Hospital - Alameda Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386540
- Sponsor's protocol ID
- IRB 14-08123E
- Status last verified
- Dec 2018
- First submitted
- 14 Feb 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
- ClinicalTrials.gov ID
- NCT02386540
- Acronym / sponsor ID
- IRB 14-08123E
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Community Health Workers, Community Health Workers: utilization, Emergency Service, Primary Health Care/utilization, Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Alameda County Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Robert Wood Johnson Foundation
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be recruited by health coaches from the Highland Hospital Emergency Department. Eligible patients who agree to participate will be randomized to the control and experimental groups in a 2:1 ratio respectively because experimental group size is limited by health coach availability and greater loss-to-follow up is expected among the control group. Repeated measures analysis will be used to compare each outcome over the study period. In addition, subgroup analyses will be performed in order to stratify by baseline survey measures or amount of ED visits in the pre-observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingPatients randomized to the experimental arm receive six months of post-ED health coaching from the Alameda County Health Coach Program (ACHCP) in addition to usual care in the emergency department at enrollment. |
| Usual Care | No intervention | –Patients randomized to the control arm receive usual care in the emergency department at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Life-expectancy less than 1 year
- Poorly controlled psychiatric illness
- Homeless
- Active and frequent use of illicit substances
- Currently incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CoachingThe Alameda County Health Coach program pairs patients with a language-concordant health coach for six months following an ED visit. Health coaches are young adults from the local community employed through Alameda County and trained for three months in topics such as self-management support and motivational interviewing. Health coaches work one-on-one with participants in order to develop an action plan in order to achieve patient-identified health goals. Communication between the health coach and participant includes text messages (weekly), phone calls (twice a month), face-to-face visits (at least once), and accompaniment to a primary care visit (at least once). Health coaches may also assist participants in accessing community resources as related to the individualized action plan. | Behavioural | Health Coaching |
Primary outcome
Number of emergency department visits
Time frame: 6 month period after enrollment
Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months.
7 secondary outcomes
Number of primary care visits
Time frame: 6 month period after enrollment
Physical health and mental health (Validated measure - SF-12v2)
Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment
Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8)
Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment
Patient activation (Validated measure - Patient Activation Measure, PAM)
Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment
Type and frequency of health coach contact
Time frame: 6 months after enrollment
Percent of action plan goals achieved (Health coach documentation notes)
Time frame: 6 months after enrollment
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)
Time frame: 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Please click here for more information about the Alameda County Health Coach Program (ACHCP).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn Freeman-Garrick, MD principal investigator
Highland Hospital - Alameda Health System
Berenice Perez, MD principal investigator
Highland Hospital - Alameda Health System
Harrison Alter, MD principal investigator
Highland Hospital - Alameda Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Diabetes Mellitus and Hypertension, run by Alameda County Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of emergency department visits (time frame: 6 month period after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.