HypertensionNCT03135405
Controlling Hypertension in Native American and Other Populations
A study testing Automated messages, Home BP monitors and Care partner reminders in people with Hypertension, run by Kaiser Permanente at 1 site in United States.
Trial summary
The study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in… Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Automated messages, Home BP monitors and Care partner reminders
- 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
- 11 Apr 2017to 28 Feb 2019
- 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least two prior visits to First Nations Community Healthsource with blood pressure measurements, with at least one visit in the 24 months prior
- Hypertension
- Between ages 21-79
Who cannot join
- Another preferred site of primary care
- Significant impairment of vision and hearing
- Life-limiting illness
- Renal dialysis
- Receipt of home health care, hospice services or residence in a nursing home
- Dementia
Show all 10Show fewer
- Pregnancy
- Current incarceration
- Homeless
- No land line or cellular phone access
Trial locations and contacts
1 site in 1 country.
United States1 site
First National Community Healthsource
Albuquerque, New Mexico, 87108
About this study
The study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the participants will receive usual care, while the other half will receive the automated calls or text messages and have the option to receive home blood pressure monitors and/or designate a care partner who will also receive messages. Participants will be followed for 12 months.
Read the detailed description
American Indians and Alaskan Natives (AI/ANs) face pervasive health disparities in comparison to other racial and ethnic groups in the United States. Treatment of hypertension is a pillar of cardiovascular disease prevention. Hypertension is the most common chronic health condition in the U.S. Uncontrolled hypertension increases the risk of acute myocardial infarction, stroke, kidney failure, and congestive heart failure. Hypertension rates are high, levels of control are low, and disparities in care are evident in AI/AN populations.
This study will take place at First Nations Community Healthsource (FNCH) in Albuquerque, New Mexico. FNCH provides primary medical care to urban AI/AN and other socially disadvantaged residents of the Albuquerque, New Mexico area. Approximately 40% of FNCH clients are AI/AN; Diné (Navajo) is the most common tribal affiliation. Many other clients served by FNCH are undocumented immigrants. Housing insecurity and homelessness are common.
This study will use a FNCH hypertension registry to identify all clients with hypertension (regardless of race or ethnicity). From this group, the study will recruit 512 clients, and randomize the participants without stratification to receive automated messages using an interactive voice recognition and text message intervention or to continue in usual care. Consistent with the principles of pragmatic randomized clinical trials, the study has few exclusion criteria in order to maximize inclusion of clients and generalizability of findings. Potentially eligible clients will be contacted by letter and phone. Those who express interest will complete a baseline visit where they provide informed consent, complete a baseline survey, and have blood pressure measured. The participants will then be randomized either to the intervention or usual care arms. Individuals randomized to the intervention arm will receive: reminders of upcoming appointments at FNCH; requests to reschedule missed appointments; reminders to refill medications; and weekly motivational messages to encourage self-care, appointment keeping, and medication-taking for hypertension. These participants will be offered a home blood pressure monitor and trained to use it if they accept, and will be asked if they wish to nominate a care partner to also receive notices of upcoming and missed appointments. In additional to their usual visits at FNCH, all participants will complete research visits with our study coordinators at 6 and 12 months, where they will again have BP measured and complete brief surveys.
- Conditions
- Hypertension
- Being tested
- Automated messages, Home BP monitors, Care partner reminders
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated messagesBehavioural
Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
Home BP monitorsBehavioural
Participants will have the option of receiving home blood pressure monitors.
Care partner remindersBehavioural
Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Automated messages; Behavioral: Home BP monitors; Behavioral: Care partner reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Change in systolic blood pressure from baseline
Measured: 12-months
Secondary outcomes (3)
Diastolic blood pressure
Change in diastolic blood pressure from baseline
Measured: 12-months
Medication adherence
Self-reported medication adherence using the Voils instrument
Measured: 12-months
Visit adherence
Proportion of scheduled appointments that are kept, missed or cancelled
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start11 Apr 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
- Responsible party
- Principal investigator, Emily Schroeder, Kaiser Permanente
- Investigators
- Emily B Schroeder, MD, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135405
- Sponsor's protocol ID
- CO-16-2400
- Other IDs
- 2P30DK092923, K23DK099237
- Status last verified
- May 2019
- First submitted
- 27 Apr 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schroeder EB, Moore KR, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MP, Son-Stone L, Johnson D, Steiner JF. A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension. J Clin Hypertens (Greenwich). 2020 Jul;22(7):1228-1238. doi: 10.1111/jch.13909. Epub 2020 Jun 9.
PubMed 32516486Schroeder EB, Moore K, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MM, Johnson D, Son-Stone L, Steiner JF. An Interactive Voice Response and Text Message Intervention to Improve Blood Pressure Control Among Individuals With Hypertension Receiving Care at an Urban Indian Health Organization: Protocol and Baseline Characteristics of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e11794. doi: 10.2196/11794.
PubMed 30938688
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Hypertension in Native American and Other Populations
- ClinicalTrials.gov ID
- NCT03135405
- Acronym / sponsor ID
- CO-16-2400
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 1 May 2017 (actual)
- 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 study evaluates the use of automated motivational messages, visit reminders, and medication reminders (using interactive voice response technology or text messages) to improve blood pressure control among adults with hypertension that receive their care at the First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the participants will receive usual care, while the other half will receive the automated calls or text messages and have the option to receive home blood pressure monitors and/or designate a care partner who will also receive messages. Participants will be followed for 12 months.
Detailed description
American Indians and Alaskan Natives (AI/ANs) face pervasive health disparities in comparison to other racial and ethnic groups in the United States. Treatment of hypertension is a pillar of cardiovascular disease prevention. Hypertension is the most common chronic health condition in the U.S. Uncontrolled hypertension increases the risk of acute myocardial infarction, stroke, kidney failure, and congestive heart failure. Hypertension rates are high, levels of control are low, and disparities in care are evident in AI/AN populations.
This study will take place at First Nations Community Healthsource (FNCH) in Albuquerque, New Mexico. FNCH provides primary medical care to urban AI/AN and other socially disadvantaged residents of the Albuquerque, New Mexico area. Approximately 40% of FNCH clients are AI/AN; Diné (Navajo) is the most common tribal affiliation. Many other clients served by FNCH are undocumented immigrants. Housing insecurity and homelessness are common.
This study will use a FNCH hypertension registry to identify all clients with hypertension (regardless of race or ethnicity). From this group, the study will recruit 512 clients, and randomize the participants without stratification to receive automated messages using an interactive voice recognition and text message intervention or to continue in usual care. Consistent with the principles of pragmatic randomized clinical trials, the study has few exclusion criteria in order to maximize inclusion of clients and generalizability of findings. Potentially eligible clients will be contacted by letter and phone. Those who express interest will complete a baseline visit where they provide informed consent, complete a baseline survey, and have blood pressure measured. The participants will then be randomized either to the intervention or usual care arms. Individuals randomized to the intervention arm will receive: reminders of upcoming appointments at FNCH; requests to reschedule missed appointments; reminders to refill medications; and weekly motivational messages to encourage self-care, appointment keeping, and medication-taking for hypertension. These participants will be offered a home blood pressure monitor and trained to use it if they accept, and will be asked if they wish to nominate a care partner to also receive notices of upcoming and missed appointments. In additional to their usual visits at FNCH, all participants will complete research visits with our study coordinators at 6 and 12 months, where they will again have BP measured and complete brief surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Intervention | Experimental | Behavioral: Automated messages, Behavioral: Home BP monitors, Behavioral: Care partner reminders |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least two prior visits to First Nations Community Healthsource with blood pressure measurements, with at least one visit in the 24 months prior
- Hypertension
- Between ages 21-79
Key exclusion criteria (10 listed)
- Another preferred site of primary care
- Significant impairment of vision and hearing
- Life-limiting illness
- Renal dialysis
- Receipt of home health care, hospice services or residence in a nursing home
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 |
|---|---|---|
| Automated messagesAutomated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages. | Behavioural | Intervention |
| Home BP monitorsParticipants will have the option of receiving home blood pressure monitors. | Behavioural | Intervention |
| Care partner remindersParticipants will have the option of designating a care partner who will also receive automated reminder calls or text messages. | Behavioural | Intervention |
Primary outcome
Systolic blood pressure
Time frame: 12-months
Change in systolic blood pressure from baseline
3 secondary outcomes
Diastolic blood pressure
Time frame: 12-months
Medication adherence
Time frame: 12-months
Visit adherence
Time frame: 12-months
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 9 May 2019.
- Derived from this study: PubMed 32516486Schroeder EB, Moore KR, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MP, Son-Stone L, Johnson D, Steiner JF. A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension. J Clin Hypertens (Greenwich). 2020 Jul;22(7):1228-1238. doi: 10.1111/jch.13909. Epub 2020 Jun 9.
- Derived from this study: PubMed 30938688Schroeder EB, Moore K, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MM, Johnson D, Son-Stone L, Steiner JF. An Interactive Voice Response and Text Message Intervention to Improve Blood Pressure Control Among Individuals With Hypertension Receiving Care at an Urban Indian Health Organization: Protocol and Baseline Characteristics of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e11794. doi: 10.2196/11794.
- Individual participant dataSharing planned: No
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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.
Emily B Schroeder, MD, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated messages, Home BP monitors and Care partner reminders in people with Hypertension, run by Kaiser Permanente 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 3 inclusion and 10 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 9 May 2019. 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?
Systolic blood pressure (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135405, which also lists 2 linked publications.
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 9 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.