HypertensionNCT03596242
SMS System for Patients With Uncontrolled Hypertension
A study testing SMS System in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- SMS System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 6 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who have been diagnosed with hypertension
- 18 and older
- stage 2 hypertension or greater systolic blood pressure [(SBP)>140 and diastolic blood pressure (DBP) >90] who are receiving antihypertensive treatment.
Who cannot join
- Pregnancy
- end-stage renal disease (on hemodialysis or peritoneal dialysis)
- hospice or nursing home care
- dementia
- Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Short Message Service System for Patients With Uncontrolled Hypertension
This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.
Read the detailed description
The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.
- Conditions
- Hypertension
- Being tested
- SMS System, blood pressure control education
- Keywords
- high blood pressure, SMS, text messaging, monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS SystemOther
Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control educationBehavioural
standard blood pressure control education given during visits
| Study group | Role | What they receive |
|---|---|---|
| High Blood Pressure Monitoring by Short Message Service (SMS) | Experimental | Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits Receives: Other: SMS System; Behavioral: blood pressure control education |
| Usual Care Plus Standard Blood Pressure Monitoring | Active comparator | Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits Receives: Behavioral: blood pressure control education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Screened
Measured: during screening period, about 6 months
Number of Subjects Enrolled
Measured: during baseline period, about 4 months
Number of Subjects Who Refuse Participation
number of participants who refuse to participate at the time of recruitment and the reason why
Measured: baseline
Number of Subjects Excluded Without SMS Capability
Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
Measured: baseline
Proportion of Participants Continuing myHealth
the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention
Measured: up to 12 weeks
Number of Participants Who Responded to SMS With At Least One Home BP Measurement
Measured: up to 12 weeks
SMS Participation
The number of patients who participate in SMS will be recorded
Measured: up to 12 weeks
System Usability Scale (SUS)
Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability.
Measured: Week 12
Secondary outcomes (7)
Medication Adherence
The number of patients who demonstrate medication compliance via SMS will be recorded.
Measured: up to 12 weeks
Medication Adherence Questionnaire
Score ranges from 0 to 10 with higher score denoting better medication adherence.
Measured: baseline, week 12
Monitoring of SBP
Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
Measured: baseline and 12 weeks
Monitoring of DBP
Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
Measured: baseline and 12 weeks
Initial and Follow up BP in Office
Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.
Measured: baseline/day 0 and 12 weeks
Number of Participants Considered No-Shows at Clinic Visits
No-show rate at 3 months' follow-up (f/u) clinic visits. If participants fail to come to their f/u visits within 7 days of their scheduled follow-up appointment, they will be considered as "no- shows".
Measured: week 12
Coordinator Time
The time spent by the coordinator on study related patient activities will be recorded
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start9 Mar 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Claudia Campos, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596242
- Sponsor's protocol ID
- IRB00051763
- Other IDs
- 5UL1TR001420-03
- Status last verified
- Mar 2023
- First submitted
- 11 Jul 2018
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lauffenburger JC, Choudhry NK. Text Messaging and Patient Engagement in an Increasingly Mobile World. Circulation. 2016 Feb 9;133(6):555-6. doi: 10.1161/CIRCULATIONAHA.116.021182. Epub 2016 Jan 14. No abstract available.
PubMed 26769741Campos CL, Jones D, Snively BM, Rocco M, Pedley C, Atwater S, Moore JB. Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 14;10(5):e18984. doi: 10.2196/18984.
PubMed 33988513
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Message Service System for Patients With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT03596242
- Acronym / sponsor ID
- IRB00051763
- Conditions
- Hypertension
- Keywords
- high blood pressure, SMS, text messaging, monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.
Detailed description
The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Blood Pressure Monitoring by Short Message Service (SMS) | Experimental | Other: SMS System, Behavioral: blood pressure control educationWill receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits |
| Usual Care Plus Standard Blood Pressure Monitoring | Active comparator | Behavioral: blood pressure control educationWill receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have been diagnosed with hypertension
- 18 and older
- stage 2 hypertension or greater systolic blood pressure [(SBP)>140 and diastolic blood pressure (DBP) >90] who are receiving antihypertensive treatment.
Key exclusion criteria (5 listed)
- Pregnancy
- end-stage renal disease (on hemodialysis or peritoneal dialysis)
- hospice or nursing home care
- dementia
- Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.
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 |
|---|---|---|
| SMS SystemParticipants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence | Other | High Blood Pressure Monitoring by Short Message Service (SMS) |
| blood pressure control educationstandard blood pressure control education given during visits | Behavioural | High Blood Pressure Monitoring by Short Message Service (SMS), Usual Care Plus Standard Blood Pressure Monitoring |
Primary outcome
Number of Participants Screened
Time frame: during screening period, about 6 months
Number of Subjects Enrolled
Time frame: during baseline period, about 4 months
Number of Subjects Who Refuse Participation
Time frame: baseline
number of participants who refuse to participate at the time of recruitment and the reason why
Number of Subjects Excluded Without SMS Capability
Time frame: baseline
Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
Proportion of Participants Continuing myHealth
Time frame: up to 12 weeks
the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention
Number of Participants Who Responded to SMS With At Least One Home BP Measurement
Time frame: up to 12 weeks
SMS Participation
Time frame: up to 12 weeks
The number of patients who participate in SMS will be recorded
System Usability Scale (SUS)
Time frame: Week 12
Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability.
7 secondary outcomes
Medication Adherence
Time frame: up to 12 weeks
Medication Adherence Questionnaire
Time frame: baseline, week 12
Monitoring of SBP
Time frame: baseline and 12 weeks
Monitoring of DBP
Time frame: baseline and 12 weeks
Initial and Follow up BP in Office
Time frame: baseline/day 0 and 12 weeks
Number of Participants Considered No-Shows at Clinic Visits
Time frame: week 12
Coordinator Time
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26769741Lauffenburger JC, Choudhry NK. Text Messaging and Patient Engagement in an Increasingly Mobile World. Circulation. 2016 Feb 9;133(6):555-6. doi: 10.1161/CIRCULATIONAHA.116.021182. Epub 2016 Jan 14. No abstract available.
- Derived from this study: PubMed 33988513Campos CL, Jones D, Snively BM, Rocco M, Pedley C, Atwater S, Moore JB. Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 14;10(5):e18984. doi: 10.2196/18984.
- 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.
Claudia Campos, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS System in people with Hypertension, run by Wake Forest University Health Sciences 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 5 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 28 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Screened (time frame: during screening period, about 6 months). The study lists 8 primary outcomes in all. 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 NCT03596242, 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 28 Sep 2023.