- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03274089
Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Singapore, Singapore
- Reclutamento
- SingHealth Polyclinics - Punggol
-
Contatto:
- Executive
- Numero di telefono: 6643 6969
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Kiosk intervention group
|
SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
Altri nomi:
|
Nessun intervento: Nurse clinician control group
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Pressione sanguigna
Lasso di tempo: 12 mesi
|
12 mesi
|
Emoglobina A1c
Lasso di tempo: 12 mesi
|
12 mesi
|
Disease control
Lasso di tempo: 12 months
|
12 months
|
Low-density lipoprotein cholesterol
Lasso di tempo: 12 months
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Eventi avversi
Lasso di tempo: 12 mesi
|
12 mesi
|
|
Visit duration
Lasso di tempo: 8 months
|
8 months
|
|
Patient satisfaction questionnaire
Lasso di tempo: 12 months
|
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.
|
12 months
|
Health-related quality of life questionnaire
Lasso di tempo: 12 months
|
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
|
12 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1629027001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Kiosk intervention group
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletatoMalattie trasmesse sessualmente | Contraccezione | Comportamento riproduttivo
-
University of PittsburghReclutamentoDistrofia muscolare di DuchenneStati Uniti
-
Sarah MorrowLawson Health Research InstituteCompletato
-
University of TulsaTerminatoSuicidio, tentatoStati Uniti
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
-
M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
-
Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
-
Lisbon Institute of Global Mental Health - LIGMHColumbia UniversityReclutamentoDisturbi psicotici | Schizofrenia | Disordine bipolare | Disturbo affettivo schizoidePortogallo
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgSconosciuto
-
Icahn School of Medicine at Mount SinaiReclutamento