- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03167866
Effect of Motivation Text Messages on Diabetes Patients
The Influence of Motivational Text Messages on Glycemic Control and Healthy Lifestyle Choices in Patients With Diabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. They will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. The patients get a weekly text message and after 26 weeks we will check the HbA1c and quality of life. The text message will be personalized by including personal details acquired by a questionnaire. They will provide demographic and clinical information.
In addition, the influence of demographic characters and related DM character on the benefit of the motivational SMS will be assessed.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Haifa, Israel
- Rambam Health Care Campus
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Uncontrolled DM 2 patients (HbA1c > 8%)
- Know to read (Hebrew or Arabic)
- Have a cellular phone
- Can sign informed consent.
Exclusion Criteria:
- A life expectancy of less than one year
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: control group
DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks.
informational SMS
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the participant a weekly text message that is provides information on improving lifestyle
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|
Eksperimentel: test group
DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks.
motivational SMS
|
the participant receives a weekly text message that is aimed to increase motivation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c levels at 6 months from beginning of messages
Tidsramme: at 6 months from beginning of study
|
Blood HbA1c levels are reflective of how well diabetes is controlled
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at 6 months from beginning of study
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diabetes Quality of Life questionnaire
Tidsramme: at 6 months from beginning of study
|
To design and test the reliability and validity of a brief treatment
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at 6 months from beginning of study
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Irit Hochberg, MD/PhD, Rambam Healthcare Campus
Publikationer og nyttige links
Generelle publikationer
- Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
- Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.
- Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.
- Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.
- Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 66666
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Diabetes mellitus, type 2
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Instituto Nacional de Ciencias Medicas y Nutricion...Aktiv, ikke rekrutterende
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes | Type 2 diabetes mellitus (T2DM) | Type 2 Diabetes
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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi... og andre samarbejdspartnereIkke rekrutterer endnuType 2 diabetes | Diabetes mellitus type 2Tyrkiet (Türkiye)
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University Hospital Inselspital, BerneAfsluttetType 2 diabetes mellitusSchweiz
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India Diabetes Research Foundation & Dr. A. Ramachandran...Afsluttet
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Endogenex, Inc.Ikke rekrutterer endnuDiabetes mellitus, type 2 | Diabetes | Type 2 diabetes mellitus | Type 2 diabetes | Type 2 diabetes
-
El Katib HospitalIkke rekrutterer endnuType 2 diabetes mellitus (T2DM)
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He Eye HospitalIkke rekrutterer endnu
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Diabetes Solutions InternationalDexCom, Inc.; Tidepool; MAVEN ProjectRekrutteringType 2 diabetes mellitus (T2DM)Forenede Stater
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Global Institute of Stem Cell Therapy and ResearchIkke rekrutterer endnu
Kliniske forsøg med informational SMS
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University of WashingtonUniversity of California, San Francisco; Kenya Medical Research InstituteAfsluttetHIV-infektioner | Erhvervet immundefektsyndromKenya
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University of WashingtonUniversity of Illinois at Chicago; Kenya Medical Research InstituteAfsluttetHIV-infektioner | Erhvervet immundefektsyndrom | Omskæring, Mand | Patient Compliance | MobiltelefonKenya
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Guangzhou Blood CenterAfsluttet
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University of MichiganUniversidad de Los Andes, Bogota, ColombiaAfsluttet
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University of Illinois at Urbana-ChampaignUniversity of Minnesota; The University of The West IndiesAfsluttet
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University of PittsburghUniversity of PennsylvaniaAfsluttetRisikoreduktionForenede Stater
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Guangzhou Blood CenterUkendt
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St. Louis UniversityAfsluttetSMS | Uddannelse, Medicin, BachelorForenede Stater
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Bandim Health ProjectUkendt
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Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative...AfsluttetED til EPI: Brug af SMS til at forbedre overgangen fra akutafdelingen til tidlig psykoseinterventionSkizofreni | Skizofrenispektrum og andre psykotiske lidelser | Skizoaffektiv lidelse | Maniodepressiv | Psykose | Skizofreniforme lidelser | Stof-inducerede psykoser | Psykotisk episode | Første episode psykose | Psykoser, Affektive | Depressiv psykoseCanada