Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control
NCT ID: NCT04932356
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
76 participants
INTERVENTIONAL
2021-05-10
2023-04-30
Brief Summary
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The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2.
In the majority of patients their follow-up is carried out from primary care, where they occupy a third of the visits, it is a main reason for consultation.
The mobile phone is becoming an interesting tool for therapeutic education.
The objective: To decrease the HbA1c value by 10% in patients who have their HbA1c \>9% and 0.5% in those who have an HbA1c value \<9%-Reduce the number of spontaneous visits in nursing consultations.
Know the attitude and motivations of the patients participating in the study It will be a probabilistic randomized intervention study at the Mas Font Primary Care Center in Viladecans (Barcelona).
According to medical history as of December 31, 2020, there were 1554 patients diagnosed with DM2, 402 DM2 patients with poor control (HbA1c \>8%) Patients who meet inclusion criteria will be contacted by telephone or at consultations and will be offered to participate and sign consent.
They are then automatically randomized to intervention or control group. Study participants will be visited in person every six months and both groups will follow the center's protocol in face-to-face visits, The intervention group will be reinforced with a fortnightly telephone visit.
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Detailed Description
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-age: in Limitations and possible biases One limitation that we can find is that the data on the follow-up of the medication varies, since during a year the patient can change treatment, due to hospital admission (variable that will be collected in both groups and a stratified analysis will be performed if necessary).
The loss of follow-up of patients due to different causes (such as patients who can change cities during vacation periods and difficult telephone locations due to difficulties in coverage, changes of residence). The final impact of the study and the reason for the losses will be evaluated.
Lack of feedback between the patient and the nurse
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Therapeutic Education by phone
Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit and then reinforcement each 15 days over the weak points of this visit.
Therapeutic education by phone
The patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time.
Traditional Therapeutic Education
Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit.
Therapeutical education traditional
The patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment.
Interventions
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Therapeutic education by phone
The patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time.
Therapeutical education traditional
The patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment.
Eligibility Criteria
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Inclusion Criteria
* With some form of drug medication for their diabetes.
Exclusion Criteria
* psychiatric disease
* hearing or vocalization problems,
* terminal patient in PADES,
* patient with chronic acute disease (MACA),
* the denial of participating in the study.
40 Years
80 Years
ALL
No
Sponsors
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Mª Dolores Rodríguez Garrido
OTHER
Responsible Party
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Mª Dolores Rodríguez Garrido
Principal investigator
Principal Investigators
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MªDolores Rodriguez, diploma
Role: PRINCIPAL_INVESTIGATOR
ICS
Locations
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MªDolores Rodriguez
Viladecans, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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J.M. Hernández, J. Basora, X. Ansa, J.L. Piñol, M. Millan, D. Figuerola. La versión española de la Diabetes Attitude Scale (DAS-3sp): un instrumento de medición de actitudes y motivaciones en Diabetes. Endocrinol Nutr., 49 (2002), pp. 293-298
Roca-Espino D, Orois-Añón A. El control de la diabetes a distancia. ¿Cuánto hay de verdaderamente útil bajo el término telemedicina? Avances en Diabetología 2015; 31(1):1-7.
Picón César MJ. Documento de posicionamiento sobre el uso de la telemedicina aplicada a la atencion diabetologica. Avances en diabetología 2010;26(3):147-150.
Zhou P, Xu L, Liu X, Huang J, Xu W, Chen W. Web-based telemedicine for management of type 2 diabetes through glucose uploads: a randomized controlled trial. Int J Clin Exp Pathol. 2014 Dec 1;7(12):8848-54. eCollection 2014.
Edmonds M, Bauer M, Osborn S, Lutfiyya H, Mahon J, Doig G, Grundy P, Gittens C, Molenkamp G, Fenlon D. Using the Vista 350 telephone to communicate the results of home monitoring of diabetes mellitus to a central database and to provide feedback. Int J Med Inform. 1998 Aug-Sep;51(2-3):117-25. doi: 10.1016/s1386-5056(98)00109-9.
Dennis SM, Harris M, Lloyd J, Powell Davies G, Faruqi N, Zwar N. Do people with existing chronic conditions benefit from telephone coaching? A rapid review. Aust Health Rev. 2013 Jun;37(3):381-8. doi: 10.1071/AH13005.
Kaur R, Kajal KS, Kaur A, Singh P. Telephonic Consultation and follow-up in Diabetics: Impact on Metabolic Profile, Quality of Life, and Patient Compliance. N Am J Med Sci. 2015 May;7(5):199-207. doi: 10.4103/1947-2714.157483.
Munshi MN, Segal AR, Suhl E, Ryan C, Sternthal A, Giusti J, Lee Y, Fitzgerald S, Staum E, Bonsignor P, DesRochers L, McCartney R, Weinger K. Assessment of barriers to improve diabetes management in older adults: a randomized controlled study. Diabetes Care. 2013 Mar;36(3):543-9. doi: 10.2337/dc12-1303. Epub 2012 Nov 27.
Izquierdo RE, Knudson PE, Meyer S, Kearns J, Ploutz-Snyder R, Weinstock RS. A comparison of diabetes education administered through telemedicine versus in person. Diabetes Care. 2003 Apr;26(4):1002-7. doi: 10.2337/diacare.26.4.1002.
Holtz B, Lauckner C. Diabetes management via mobile phones: a systematic review. Telemed J E Health. 2012 Apr;18(3):175-84. doi: 10.1089/tmj.2011.0119. Epub 2012 Feb 22.
Esmatjes E, Jansa M, Roca D, Perez-Ferre N, del Valle L, Martinez-Hervas S, Ruiz de Adana M, Linares F, Batanero R, Vazquez F, Gomis R, de Sola-Morales O; Telemed-Diabetes Group. The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study. Diabetes Technol Ther. 2014 Jul;16(7):435-41. doi: 10.1089/dia.2013.0313. Epub 2014 Feb 14.
Klonoff DC. Using telemedicine to improve outcomes in diabetes--an emerging technology. J Diabetes Sci Technol. 2009 Jul 1;3(4):624-8. doi: 10.1177/193229680900300401. No abstract available.
Zolfaghari M, Mousavifar SA, Haghani H. Mobile phone text messaging and Telephone follow-up in type 2 diabetic patients for 3 months: a comparative study. J Diabetes Metab Disord. 2012 Aug 24;11(1):7. doi: 10.1186/2251-6581-11-7.
Zhai YK, Zhu WJ, Cai YL, Sun DX, Zhao J. Clinical- and cost-effectiveness of telemedicine in type 2 diabetes mellitus: a systematic review and meta-analysis. Medicine (Baltimore). 2014 Dec;93(28):e312. doi: 10.1097/MD.0000000000000312.
McGloin H, Timmins F, Coates V, Boore J. A case study approach to the examination of a telephone-based health coaching intervention in facilitating behaviour change for adults with Type 2 diabetes. J Clin Nurs. 2015 May;24(9-10):1246-57. doi: 10.1111/jocn.12692. Epub 2014 Oct 16.
Nuti L, Turkcan A, Lawley MA, Zhang L, Sands L, McComb S. The impact of interventions on appointment and clinical outcomes for individuals with diabetes: a systematic review. BMC Health Serv Res. 2015 Sep 2;15:355. doi: 10.1186/s12913-015-0938-5.
Related Links
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Human Experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki.
Construcción de un índice de privación a partir de datos censales en grandes ciudades españolas: (Proyecto MEDEA).
10\. Orozco-Beltrán D, et al. Abordaje de la adherencia en diabetes mellitus tipo 2: situación actual y propuesta de posibles soluciones.
Other Identifiers
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4R16/146
Identifier Type: -
Identifier Source: org_study_id
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