Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
Primary Purpose
Hypertension, Hyperlipidemia; Mixed, Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Kiosk intervention group
Sponsored by
About this trial
This is an interventional other trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- are between the ages of 21 and 75 years
- have at least one chronic medical condition that includes hypertension, hyperlipidemia, diabetes mellitus
- have blood pressure, low-density lipoprotein cholesterol (LDL-C) and HbA1c levels within the recommended targets according to the Ministry of Health Singapore clinical practice guidelines for their current and last follow-up visits
- are able to provide informed consent.
Exclusion Criteria:
- have serum creatinine more than 140 mmol/L (from tests done within the past year)
- have serum potassium less than 3.5 mmol/L or more than 5 mmol/L (from tests done within the past year)
- have overt proteinuria (urine protein:creatinine ratio more than 0.5)
- were discharged from hospital or specialist follow-up within the last 6 months
- have any pending laboratory or investigation result
- are scheduled for any laboratory investigation within the next 4 months (except HbA1c or panel test)
- have any new complaint related to their chronic medical conditions
- have a known history of white coat hypertension
Sites / Locations
- SingHealth Polyclinics - PunggolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Kiosk intervention group
Nurse clinician control group
Arm Description
Outcomes
Primary Outcome Measures
Disease control
Blood pressure
Low-density lipoprotein cholesterol
Hemoglobin A1c
Secondary Outcome Measures
Visit duration
Patient satisfaction questionnaire
The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician. Qualitative feedback will be captured via free-text inputs.
Adverse events
Health-related quality of life questionnaire
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
Full Information
NCT ID
NCT03274089
First Posted
September 4, 2017
Last Updated
June 21, 2018
Sponsor
SingHealth Polyclinics
Collaborators
Agency for Science, Technology and Research
1. Study Identification
Unique Protocol Identification Number
NCT03274089
Brief Title
Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
Official Title
A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SingHealth Polyclinics
Collaborators
Agency for Science, Technology and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The chronic disease burden is increasing worldwide leading to a rise in the demand for primary healthcare and a shortage of primary care physicians. Addressing this shortage entails a multi-prong approach with innovations in care delivery, greater use of healthcare technology, and more efficient use of all healthcare providers on the care team.
We previously developed an interactive self-service healthcare kiosk (Self-empowering and enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. A feasibility study using SEEK showed high levels of acceptance and satisfaction from patients and healthcare providers.
The aim of this follow-up study is to evaluate the health outcomes of patients with stable chronic disease who are on kiosk management compared to patients who are on routine management by nurse clinicians. We hypothesize that patients who are managed by the kiosk continue to maintain good disease control that are comparable to patients who are managed by a nurse clinician.
Detailed Description
Patients who seek primary healthcare vary in their time and resource requirements. Patients with acute medical conditions or poorly controlled chronic disease typically require more time and attention compared to patients with stable chronic disease.
Patients with chronic disease routinely make follow-up visits to their primary care provider for assessment of their chronic disease status and for changes to their medications as necessary. Patients with well-controlled stable chronic disease may go through several visits to their primary care provider in 3 or 4-monthly intervals with little or no change to their medication regimen. These patients have to wait in line with the rest of the patient crowd for a doctor's consultation before getting their regular supply of medications. We hence saw the potential of replacing some of these physician visits with an automated healthcare kiosk so that if the disease condition of such patients remained stable, they can continue on their current medications without having to see a doctor.
We previously described the feasibility of using an automated healthcare kiosk (SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. We propose a follow-up study to show equivalence of health outcomes for patients managed with SEEK compared to the current standard of care. The study will be a 2-armed randomized controlled trial of 120 patients with stable chronic disease on 4-monthly follow-up visits over a 12-month period. Patients will be assigned randomly to intervention or control groups to receive kiosk or nurse management respectively. The main primary outcome measure is the overall chronic disease control of the patients. Other primary outcome measures are the blood pressure and low-density lipoprotein cholesterol levels for patients without diabetes; and blood pressure, low-density lipoprotein cholesterol and hemoglobin A1c levels for patients with diabetes. Secondary outcome measures are visit duration, patient satisfaction with the management process, health-related quality of life, and the occurrence of any adverse event.
The potential benefits from the use of SEEK are:
Appropriate stratification of patient care needs so that more time and resources can be channeled to patients with complex or acute needs;
Patient empowerment in the management of their chronic health conditions, with flexibility of self-care and monitoring and decreased dependency on healthcare providers;
Substitution of nurse clinicians for the management of stable chronic disease;
Reduction in the number of doctor visits per year for patients with stable chronic disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia; Mixed, Diabetes Mellitus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kiosk intervention group
Arm Type
Experimental
Arm Title
Nurse clinician control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Kiosk intervention group
Other Intervention Name(s)
SEEK® MyHealthKiosk
Intervention Description
SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
Collects patient information using patient-specific identification
Prompts the user for answers to screening questions for acute conditions
Measures relevant physiological parameters: blood pressure, height, weight; and calculates body mass index
Triages patients based on responses to screening questions, physiological parameters and blood test results
Provides recommendations to the patient on the care plan, self management and lifestyle choices
Primary Outcome Measure Information:
Title
Disease control
Time Frame
12 months
Title
Blood pressure
Time Frame
12 months
Title
Low-density lipoprotein cholesterol
Time Frame
12 months
Title
Hemoglobin A1c
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visit duration
Time Frame
8 months
Title
Patient satisfaction questionnaire
Description
The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician. Qualitative feedback will be captured via free-text inputs.
Time Frame
12 months
Title
Adverse events
Time Frame
12 months
Title
Health-related quality of life questionnaire
Description
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are between the ages of 21 and 75 years
have at least one chronic medical condition that includes hypertension, hyperlipidemia, diabetes mellitus
have blood pressure, low-density lipoprotein cholesterol (LDL-C) and HbA1c levels within the recommended targets according to the Ministry of Health Singapore clinical practice guidelines for their current and last follow-up visits
are able to provide informed consent.
Exclusion Criteria:
have serum creatinine more than 140 mmol/L (from tests done within the past year)
have serum potassium less than 3.5 mmol/L or more than 5 mmol/L (from tests done within the past year)
have overt proteinuria (urine protein:creatinine ratio more than 0.5)
were discharged from hospital or specialist follow-up within the last 6 months
have any pending laboratory or investigation result
are scheduled for any laboratory investigation within the next 4 months (except HbA1c or panel test)
have any new complaint related to their chronic medical conditions
have a known history of white coat hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Ng
Phone
+65 6377 8771
Email
grace.ng.b.h@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Caris Tan
Phone
+65 6377 7107
Email
tan.yang.thong@singhealth.com.sg
Facility Information:
Facility Name
SingHealth Polyclinics - Punggol
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Executive
Phone
6643 6969
12. IPD Sharing Statement
Citations:
PubMed Identifier
29574445
Citation
Ng G, Tan SW, Tan NC. Health outcomes of patients with chronic disease managed with a healthcare kiosk in primary care: protocol for a pilot randomised controlled trial. BMJ Open. 2018 Mar 23;8(3):e020265. doi: 10.1136/bmjopen-2017-020265.
Results Reference
derived
Learn more about this trial
Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
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