NCT03274089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

June 21, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

September 4, 2017

Last Update Submit

June 21, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Disease control

    12 months

  • Blood pressure

    12 months

  • Low-density lipoprotein cholesterol

    12 months

  • Hemoglobin A1c

    12 months

Secondary Outcomes (4)

  • Visit duration

    8 months

  • Patient satisfaction questionnaire

    12 months

  • Adverse events

    12 months

  • Health-related quality of life questionnaire

    12 months

Study Arms (2)

Kiosk intervention group

EXPERIMENTAL
Device: Kiosk intervention group

Nurse clinician control group

NO INTERVENTION

Interventions

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

Also known as: SEEK® MyHealthKiosk
Kiosk intervention group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Polyclinics - Punggol

Singapore, Singapore

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypertensionHyperlipoproteinemia Type IIDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Physician

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

June 21, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations