Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management (T+)
9. april 2012 opdateret af: Justine Baron, University College London Hospitals
Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease.
More recently the focus has been moving to portable systems equipped with Bluetooth.
This study consists of evaluating an application called the Think Positive (T+) diabetes management software.
It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system.
The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable.
The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined.
Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
86
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, W1W 7EJ
- University College London (UCL)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Type 1 and type 2 diabetes patients
- Insulin requiring patients
- Sufficiently fluent in english
- HbA1c > 7.5
- Last visit with Diabetes Specialist Nurse (DSN) < 12 months
Exclusion Criteria:
- Psychiatric disorders
- Poor vision or/and lack of manual dexterity
- Prior use of T+
- Participation in another ongoing trial
- Patients with antenatal/gestational
- Patients who are in transition between the children services and adult services Insulin pump users
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: T+ Intervention
The intervention group patients will use the T+ telemedicine application whilst completing repeated measures aiming to compare them to a control group receiving standard care.
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T+ consists of the Glucometer paired with a cradle that transmits via Bluetooth blood glucose results to a mobile phone.
Data is stored and sent to a secure website.
The website can be accessed by the patient as well as by health care providers (HCP).
HCP can discuss data on the phone and make recommendations via text messages to patients.
Visual feedback (graphs and statistics) illustrating recent blood sugar levels patterns is automatically and immediately sent to the patient when data is transferred from the T+ phone.
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Ingen indgriben: Usual care
The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Blood sugar levels (HbA1c)
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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BMI
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Number of Hypoglycemic events
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Blood pressure
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Diabetes self-care
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Diabetes self- efficacy
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Quality of life
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Health status
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Illness representations
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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User acceptability of T+
Tidsramme: 3 months, 9 months
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3 months, 9 months
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Nurses' Perceptions of T+
Tidsramme: Baseline, 3 months, 9 months
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Baseline, 3 months, 9 months
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Self efficacy in using T+
Tidsramme: 3 months, 9 months
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3 months, 9 months
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Health care utilization
Tidsramme: baseline, 3 months, 9 months
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baseline, 3 months, 9 months
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Self management
Tidsramme: baseline, 3 months, 9 months
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2 subscales of the HeiQ questionnaire.
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baseline, 3 months, 9 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wangberg SC, Arsand E, Andersson N. Diabetes education via mobile text messaging. J Telemed Telecare. 2006;12 Suppl 1:55-6. doi: 10.1258/135763306777978515.
- Blake H. Mobile phone technology in chronic disease management. Nurs Stand. 2008 Nov 26-Dec 2;23(12):43-6. doi: 10.7748/ns2008.11.23.12.43.c6728.
- Farmer A, Gibson OJ, Tarassenko L, Neil A. A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes. Diabet Med. 2005 Oct;22(10):1372-8. doi: 10.1111/j.1464-5491.2005.01627.x.
- Faridi Z, Liberti L, Shuval K, Northrup V, Ali A, Katz DL. Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study. J Eval Clin Pract. 2008 Jun;14(3):465-9. doi: 10.1111/j.1365-2753.2007.00881.x. Epub 2008 Mar 24.
- Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.
- Kollmann A, Riedl M, Kastner P, Schreier G, Ludvik B. Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients. J Med Internet Res. 2007 Dec 31;9(5):e36. doi: 10.2196/jmir.9.5.e36.
- Baron J, Hirani S, Newman S. A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial. JMIR Res Protoc. 2015 Feb 26;4(1):e27. doi: 10.2196/resprot.4035.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Faktiske)
1. november 2011
Studieafslutning (Faktiske)
1. november 2011
Datoer for studieregistrering
Først indsendt
16. juni 2009
Først indsendt, der opfyldte QC-kriterier
16. juni 2009
Først opslået (Skøn)
17. juni 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. april 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2012
Sidst verificeret
1. april 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09/0201
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .