Trial Outcomes & Findings for Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage (NCT NCT05479097)

NCT ID: NCT05479097

Last Updated: 2024-07-16

Results Overview

Difference in systolic blood pressure from baseline to 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline, 6 months
• Results posted on: 2024-07-16

Participant Flow

Participant milestones

Measure	Study Participants All study participants were enrolled in a single arm.
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Study Participants All study participants were enrolled in a single arm.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage

Baseline characteristics by cohort

Measure	Study Participants n=32 Participants All study participants were enrolled in a single arm.
Age, Continuous	59.0 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	32 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Guatemala	32 participants n=5 Participants
Systolic blood pressure	132.0 mmHg n=5 Participants
Diastolic blood pressure	80.8 mmHg STANDARD_DEVIATION 11.0 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

Population: All participants who completed the 6 month follow-up visit

Difference in systolic blood pressure from baseline to 6 months

Outcome measures

Measure	Study Participants n=30 Participants All study participants were enrolled in a single arm.
Change in Systolic Blood Pressure	-7.5 mmHg Interval -12.0 to -1.0

PRIMARY outcome

Timeframe: baseline, 6 months

Population: Participants who completed the 6 month visit

Difference in diastolic blood pressure from baseline to 6 months

Outcome measures

Measure	Study Participants n=30 Participants All study participants were enrolled in a single arm.
Difference in Diastolic Blood Pressure From Baseline to 6 Months	-3.1 mmHg Interval -6.1 to -0.1

PRIMARY outcome

Timeframe: baseline, 6 months

Population: Study participants who completed the 6 month visit.

Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months

Outcome measures

Measure	Study Participants n=30 Participants All study participants were enrolled in a single arm.
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 Baseline systolic blood pressure control · Systolic blood pressure controlled (<=140 mmHg)	21 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 Baseline systolic blood pressure control · Systolic blood pressure not controlled (>140 mmHg)	9 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 Six month systolic blood pressure control · Systolic blood pressure controlled (<=140 mmHg)	23 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140 Six month systolic blood pressure control · Systolic blood pressure not controlled (>140 mmHg)	7 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

Population: Participants who completed the 6 month visit. Note that this outcome is the same as outcome #3 (change in proportion of patients with systolic blood pressure \<=140 mmHg) because no patients had a personalized goal different than \<=140 mmHg.

Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months

Outcome measures

Measure	Study Participants n=30 Participants All study participants were enrolled in a single arm.
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal Six months · Systolic blood pressure greater than personalized goal	7 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal Baseline · Systolic blood pressure less than or equal to personalized goal	21 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal Baseline · Systolic blood pressure greater than personalized goal	9 Participants
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal Six months · Systolic blood pressure less than or equal to personalized goal	23 Participants

PRIMARY outcome

Timeframe: 6 months

This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application.

Outcome measures

Measure	Study Participants n=209 Patient visits All study participants were enrolled in a single arm.
Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application Visits for which both CHW and physician agreed with medication recommendations	202 Patient visits
Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application Visits for which either the CHW or physician disagreed with medication recommendations	7 Patient visits

Adverse Events

Study Participants

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Participants n=32 participants at risk All study participants were enrolled in a single arm.
Gastrointestinal disorders Dyspepsia	15.6% 5/32 • Number of events 7 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
General disorders Non-cardiac chest pain	12.5% 4/32 • Number of events 6 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Metabolism and nutrition disorders Hyperglycemia	6.2% 2/32 • Number of events 2 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Nervous system disorders Dizziness	6.2% 2/32 • Number of events 2 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Vascular disorders Hypotension	6.2% 2/32 • Number of events 2 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Investigations Alanine aminotransferase increased	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Nervous system disorders Headache	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Respiratory, thoracic and mediastinal disorders Sore throat	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Gastrointestinal disorders Nausea	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Gastrointestinal disorders Gastroesophageal reflux disease	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Investigations Creatinine increased	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Nervous system disorders Syncope	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
General disorders Fatigue	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Metabolism and nutrition disorders Hypoglycemia	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.
Cardiac disorders Heart failure	3.1% 1/32 • Number of events 1 • Six months. Vitals were measured and participants were assessed for medication side effects and potential complications of hypertension at monthly visits using a standardized data collection application. Laboratory testing, including serum creatinine, electrolytes, lipid profile, blood glucose, and ALT was conducted for participants at the enrollment visit and at the 6 month visit, as well as in other points for selected subjects per the medical judgement of the supervising physician.

Additional Information

Dr. Sean Duffy

University of Wisconsin School of Medicine and Public Health

Phone: 608-263-3111

Email: sean.duffy@fammed.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place