Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control

NCT04932356 | Unknown DMC

• 1 other identifier: 4R16/146
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending. 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Educational Technology; Diabetes Mellitus Type 2; Glycated Hemoglobin A; Pragmatic Clinical Trial

Outcome Measures

Primary Outcomes (1)

• HbA1c Result

  Descriptive statistics of the variables will be carried out, using measures of central tendency and dispersion for quantitative variables and percentages with a 95% confidence interval for qualitative variables. A comparison of both groups will be carried out at the beginning of the study, using t-Student or chi-square according to the nature of the variables and if the application conditions allow it. Bivariate statistics will also be performed at the end of the study, to evaluate differences between both groups, and other independent variables, with respect to the outcome variables. Multivariate statistics will be performed, by means of logistic regression, using as the dependent variable having or not achieved the decrease in hemoglobin and as independent variables those that have shown significance at the bivariate level.

  7 months

Secondary Outcomes (1)

• patient motivation

  6 month

Study Arms (2)

Therapeutic Education by phone

OTHER

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.

Other: Therapeutic education by phone

Traditional Therapeutic Education

OTHER

Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit.

Other: Therapeutical education traditional

Interventions

Therapeutic education by phone OTHER

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.

Therapeutic Education by phone

Therapeutical education traditional OTHER

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.

Traditional Therapeutic Education

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DM2 patient with HbA1c \> of 8%
• With some form of drug medication for their diabetes.

You may not qualify if:

• persons with gestational diabetes,
• psychiatric disease
• hearing or vocalization problems,
• terminal patient in PADES,
• patient with chronic acute disease (MACA),
• the denial of participating in the study.

Sponsors & Collaborators

• Mª Dolores Rodríguez Garrido: lead

Study Sites (1)

MªDolores Rodriguez

Viladecans, Barcelona, 08840, Spain

RECRUITING

Related Publications (16)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25674254 BACKGROUND

• 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.

  PMID: 9794328 RESULT

• 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.

  PMID: 23701944 RESULT

• 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.

  PMID: 26110131 RESULT

• 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.

  PMID: 23193208 RESULT

• 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.

  PMID: 12663564 RESULT

• 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.

  PMID: 22356525 RESULT

• 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.

  PMID: 24528195 RESULT

• 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.

  PMID: 20144303 RESULT

• 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.

  PMID: 23497735 RESULT

• 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.

  PMID: 25526482 RESULT

• 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.

  PMID: 25319572 RESULT

• 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.

  PMID: 26330299 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• MªDolores Rodriguez, diploma

  ICS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MªDolores Rodriguez, diploma

CONTACT

630942731; lolirodriguezgarrido@gmail.com

Diana Romero, diploma

CONTACT

695438560; dromero@ambitcp.ics@gencat.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomly assigned to each group at the beginning of recruitment. Patients who are in the intervention group will be aware of the group in which they are because it requires biweekly telephone visits.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Fortnightly reinforcement of diabetes education, diet review, exercise, emotional support, doubts with insulin or oral medication and the registration of blood glucose controls, through telephone calls scheduled at a specific time during a semester.

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 21, 2021
• Study Start: May 10, 2021
• Primary Completion: August 31, 2022
• Study Completion: April 30, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)