HypertensionNCT03274089
Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
A study testing Kiosk intervention group in people with Hypertension and Hyperlipidemia; Mixed, run by SingHealth Polyclinics at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hypertension, Hyperlipidemia; Mixed, Diabetes Mellitus
- What is being tested?
- Kiosk intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Jun 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
SingHealth Polyclinics - Punggol
Singapore
Executive, 6643 6969
About this study
Official title: A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
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.
Read the 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.
- Conditions
- Hypertension, Hyperlipidemia; Mixed, Diabetes Mellitus
- Being tested
- Kiosk intervention group
- Medical subject headings
- Hypertension, Hyperlipoproteinemia Type II, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiosk intervention groupDevice
Also called SEEK® MyHealthKiosk
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
| Study group | Role | What they receive |
|---|---|---|
| Kiosk intervention group | Experimental | Not described Receives: Device: Kiosk intervention group |
| Nurse clinician control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control
Measured: 12 months
Blood pressure
Measured: 12 months
Low-density lipoprotein cholesterol
Measured: 12 months
Hemoglobin A1c
Measured: 12 months
Secondary outcomes (4)
Visit duration
Measured: 8 months
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.
Measured: 12 months
Adverse events
Measured: 12 months
Health-related quality of life questionnaire
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start21 Jun 2018
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Principal investigator, Grace Ng Beng Hua, SingHealth Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274089
- Sponsor's protocol ID
- 1629027001
- Status last verified
- Jun 2018
- First submitted
- 4 Sep 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29574445
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
- ClinicalTrials.gov ID
- NCT03274089
- Acronym / sponsor ID
- 1629027001
- Conditions
- Hypertension, Hyperlipidemia; Mixed, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiosk intervention group | Experimental | Device: Kiosk intervention group |
| Nurse clinician control group | No intervention | – |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kiosk intervention groupAlso: SEEK® MyHealthKioskSEEK 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 | Device | Kiosk intervention group |
Primary outcome
Disease control
Time frame: 12 months
Blood pressure
Time frame: 12 months
Low-density lipoprotein cholesterol
Time frame: 12 months
Hemoglobin A1c
Time frame: 12 months
4 secondary outcomes
Visit duration
Time frame: 8 months
Patient satisfaction questionnaire
Time frame: 12 months
Adverse events
Time frame: 12 months
Health-related quality of life questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 29574445Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiosk intervention group in people with Hypertension and Hyperlipidemia; Mixed, run by SingHealth Polyclinics at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Ng (+65 6377 8771, grace.ng.b.h@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.