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Trial Outcomes & Findings for Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care (NCT NCT04640519)

NCT ID: NCT04640519

Last Updated: 2022-10-03

Results Overview

The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be \< 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2022-10-03

Participant Flow

Participant milestones

Participant milestones
Measure
TASC Intervention
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC Control
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TASC Intervention
n=25 Participants
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC Control
n=25 Participants
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
65.9 years
STANDARD_DEVIATION 15.6 • n=5 Participants
62.6 years
STANDARD_DEVIATION 12.4 • n=7 Participants
64.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-Hispanic White
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
6 Participants
n=5 Participants
10 Participants
n=7 Participants
16 Participants
n=5 Participants
Race/Ethnicity, Customized
Dominican / Hispanic
14 Participants
n=5 Participants
8 Participants
n=7 Participants
22 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-Hispanic Other
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
25 participants
n=5 Participants
25 participants
n=7 Participants
50 participants
n=5 Participants
Systolic Blood Pressure (SBP)
139.7 mmHg
STANDARD_DEVIATION 18.9 • n=5 Participants
142.0 mmHg
STANDARD_DEVIATION 18.9 • n=7 Participants
140.9 mmHg
STANDARD_DEVIATION 18.8 • n=5 Participants
Diastolic Blood Pressure (DBP)
80.2 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
79.9 mmHg
STANDARD_DEVIATION 11.8 • n=7 Participants
80.1 mmHg
STANDARD_DEVIATION 11.1 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Population: Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients.

The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be \< 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.

Outcome measures

Outcome measures
Measure
TASC Intervention
n=21 Participants
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC Control
n=16 Participants
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Percentage of Participants With Systolic BP Control
76 percentage of participants
25 percentage of participants

PRIMARY outcome

Timeframe: 3 months

Population: Only data of evaluable participants were included in the analysis: 23 out of 25 TASC Intervention patients and 24 out of 25 TASC Control patients.

This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.

Outcome measures

Outcome measures
Measure
TASC Intervention
n=23 Participants
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC Control
n=24 Participants
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Percentage of Participants Who Completed at Least 1 Video Visit
91 percentage of participants
75 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients.

Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.

Outcome measures

Outcome measures
Measure
TASC Intervention
n=21 Participants
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
TASC Control
n=16 Participants
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Medication Adherence Percentage
67 percentage of participants
63 percentage of participants

Adverse Events

TASC Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TASC Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Imama Naqvi, MD

Columbia University

Phone: 646-426-3876

Results disclosure agreements

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