SMS System for Patients With Uncontrolled Hypertension

NCT ID: NCT03596242

Last Updated: 2023-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2021-12-06

Brief Summary

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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

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High Blood Pressure Monitoring by Short Message Service (SMS)

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

Group Type EXPERIMENTAL

SMS System

Intervention Type OTHER

Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence

blood pressure control education

Intervention Type BEHAVIORAL

standard blood pressure control education given during visits

Usual Care Plus Standard Blood Pressure Monitoring

Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits

Group Type ACTIVE_COMPARATOR

blood pressure control education

Intervention Type BEHAVIORAL

standard blood pressure control education given during visits

Interventions

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SMS System

Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence

Intervention Type OTHER

blood pressure control education

standard blood pressure control education given during visits

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26769741 (View on PubMed)

Campos 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.

Reference Type DERIVED
PMID: 33988513 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5UL1TR001420-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00051763

Identifier Type: -

Identifier Source: org_study_id

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