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Phone-based Intervention Under Nurse Guidance After Stroke 2

Primary Purpose

Blood Pressure, Stroke, Cardiovascular Diseases

Status
Active
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
PINGS 2
Sponsored by
Northern California Institute of Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 18 years (stroke is commoner above this age cut-off)
  • male or females (sex is a biologic variable of interest)
  • recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible
  • uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives <60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control
  • patients or family carers should own a basic mobile phone that can receive text/audio messages.

Exclusion Criteria:

- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).

Sites / Locations

  • Ankaase Methodist Hospital
  • Korle Bu Teaching Hospital
  • Agogo Presbyterian Hospital
  • Cape Coast Teaching Hospital
  • Komfo Anokye Teaching Hospital
  • Kumasi South Hospital
  • Kwadaso SDA Hospital
  • Kwame Nkrumah University of Science and Technology
  • Manhyia Government Hospital
  • Tafo Government Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PINGS 2

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Systolic blood pressure
Target goal of <140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.

Secondary Outcome Measures

Self-management
Compared between the two groups using the validated Hypertension Self-care Profile questionnaire (HBP SCP) with items that compositely assesses behavior, motivation and self-efficacy of hypertension management. Assessed at months 4, 8 and 12 (α.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice.
Medication adherence
Measured using Medication possession ratio177 and 14-item Hill-Bone compliance (HBC) to high blood pressure therapy scale with items that assess medication adherence, clinic appointments and salt intake assessed at months 3, 6, 9 and 12 (α.76-.83, r = .64) MPR and HBC will be measured in both PINGS and usual care arms at stated time points. Higher scores (0-14) indicate lower adherence (i.e. higher non adherence).
Number of Cardiovascular ED encounters and Re-hospitalizations
To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups. Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups.
Number of Major Adverse Cardiovascular Events
Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital.
Health-related quality of Life: The Euro Quality of Life-5D questionnaire
The EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status).

Full Information

First Posted
May 21, 2020
Last Updated
July 5, 2023
Sponsor
Northern California Institute of Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT04404166
Brief Title
Phone-based Intervention Under Nurse Guidance After Stroke 2
Official Title
Phone-based Intervention Under Nurse Guidance After Stroke 2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern California Institute of Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer term BP control among 500 recent stroke patients encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation strategy for routine integration and policy adoption of mhealth for post-stroke BP control in a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain Disorders funded R21 pilot study (NS094033) to test efficacy of a refined, culturally-tailored, and potentially implementable intervention aimed at addressing the premier modifiable risk for stroke & other key variables in an under-resourced system burdened by suboptimal care & outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Stroke, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PINGS 2
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
PINGS 2
Intervention Description
Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Target goal of <140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self-management
Description
Compared between the two groups using the validated Hypertension Self-care Profile questionnaire (HBP SCP) with items that compositely assesses behavior, motivation and self-efficacy of hypertension management. Assessed at months 4, 8 and 12 (α.83-.93, r = .64). A total score can range from 20 to 80 with higher score indicating better self-care practice.
Time Frame
12 months
Title
Medication adherence
Description
Measured using Medication possession ratio177 and 14-item Hill-Bone compliance (HBC) to high blood pressure therapy scale with items that assess medication adherence, clinic appointments and salt intake assessed at months 3, 6, 9 and 12 (α.76-.83, r = .64) MPR and HBC will be measured in both PINGS and usual care arms at stated time points. Higher scores (0-14) indicate lower adherence (i.e. higher non adherence).
Time Frame
12 months
Title
Number of Cardiovascular ED encounters and Re-hospitalizations
Description
To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups. Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups.
Time Frame
12 months
Title
Number of Major Adverse Cardiovascular Events
Description
Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital.
Time Frame
12 months
Title
Health-related quality of Life: The Euro Quality of Life-5D questionnaire
Description
The EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Health Literacy in HPT/stroke
Description
Self-Report: HTN/stroke Knowledge questionnaire (r=.70) Health literacy questionnaire (r = .74, .82) Assessed at months 0, 6,12. Higher scores indicate higher health literacy. Scales 1-5 are scored on a 4-point Likert-type response scale (strongly disagree, disagree, agree, strongly agree) and scales 6-9 are scored on a 5-point Likert-type scale with response options focusing on difficulty (cannot do or always difficult, usually difficult, sometimes difficult, usually easy, always easy).
Time Frame
12 months
Title
Disability/Functional status
Description
Functional status after stroke will be assessed by Research Assistants using the Modified Rankin Scale with a scores ranging from 0 to 6, where 0=no functional limitation and 6 = death. Assessed at months 0, 3, 6, 9 and 12.
Time Frame
12 months
Title
Sex, Age, cultural, socio-economic Factors, study site
Description
Assessed based on self reports at baseline. Cultural factors to assess include language spoken at home, religious observances, acceptance of gender roles; occupation, religious beliefs and dietary practices.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years (stroke is commoner above this age cut-off) male or females (sex is a biologic variable of interest) recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives <60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control patients or family carers should own a basic mobile phone that can receive text/audio messages. Exclusion Criteria: - Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
Facility Information:
Facility Name
Ankaase Methodist Hospital
City
Aboaso
Country
Ghana
Facility Name
Korle Bu Teaching Hospital
City
Accra
Country
Ghana
Facility Name
Agogo Presbyterian Hospital
City
Agogo
Country
Ghana
Facility Name
Cape Coast Teaching Hospital
City
Cape Coast
Country
Ghana
Facility Name
Komfo Anokye Teaching Hospital
City
Kumasi
Country
Ghana
Facility Name
Kumasi South Hospital
City
Kumasi
Country
Ghana
Facility Name
Kwadaso SDA Hospital
City
Kumasi
Country
Ghana
Facility Name
Kwame Nkrumah University of Science and Technology
City
Kumasi
Country
Ghana
Facility Name
Manhyia Government Hospital
City
Kumasi
Country
Ghana
Facility Name
Tafo Government Hospital
City
Kumasi
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
No

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Phone-based Intervention Under Nurse Guidance After Stroke 2

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