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Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control (TTEDMV1)

30 augustus 2022 bijgewerkt door: Mª Dolores Rodríguez Garrido

To Evaluate the Impact of a Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control Over Glycosylated Hemoglobin and Spontaneous Nursing Visits, in a Primary Care Center

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The study is of the probabilistic random intervention type, in a Primary Care center. The area where the study will be carried out: Population attached to ABS Mas Font over 18 years (18,431 people), in Viladecans (Barcelona). In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were found. By 2020 they had two HBa1cs registered in 402 patients (26% of all PATIENTS with DM2), only 711 (45.75%) 441 (28.4%) no. With one of the last two > 8 there are 145 patients. With the last two values > 8 there are 87 patients. Socio-economic data Typology according to CatSalut - Urban population with medium-high privacy MEDEA* ABS Viladecans Index 1 x 0'70 (Median of Catalonia 0'44) *It is a deprivation rate based on the following socio-economic indicators: manual workers, unemployment, eventual employees, total under-education and in 18 young people. Inclusion and exclusion criteria the denial of participating in the study. Sample calculation In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were consisting of 402 DM2 patients (26%) have at least two records of HbA1c. Accepting an alpha risk of 5%, beta less than 20%, in a unilateral contrast and waiting to detect a minimum difference of 0.9, for a deviation of 1.2 in HBa1c values and with losses not greater than 10%, 32 patients are required in each group. The sample should be increased by 20% in case there were drop outs, requiring a sample of 38 patients in each group to be able to find a difference in HbA1c. (IMIM GRANMO https://www.imim.es/ofertadeserveis/software-public/granmo/) Source of subjects From the list of patients who meet criteria you will get a sample Random. The collected patients will be contacted by telephone or at the consultations and offered to participate in the study. The purpose of the same will be explained and the confidentiality of the data will be ensured. If they agree to participate they will be summoned to the center where they sign the informed consent (see attached document). They are then automatically randomized to intervention or control group. Definition of variables Demographic:

-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

Studietype

Ingrijpend

Inschrijving (Verwacht)

76

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Spanje
    • Barcelona
      • Viladecans, Barcelona, Spanje, 08840
        • Werving
        • MªDolores Rodriguez
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Adriana López, diploma
        • Onderonderzoeker:
          • Marta Pereira, diploma
        • Onderonderzoeker:
          • Sonia Catalán, diploma
        • Onderonderzoeker:
          • Sara Mohamed, diploma
        • Onderonderzoeker:
          • Montserrat Sanchez, diplom

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Ander: 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.
Ander: Traditional Therapeutic Education
Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HbA1c Result
Tijdsspanne: 7 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
patient motivation
Tijdsspanne: 6 month
To evaluate the motivation and attitude of the patient with respect to his diabetes, in the initial visit and at the end of the intervention, the DAS-3sp questionnaire will be used. The proposed motivations and attitudes test is validated by J.Mª Hernandez et al. 19 (annex two). Where the changes in the global score of the scale between the visit at the beginning and at the end of the intervention will be assessed, comparing the initial and final tests.
6 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mª Dolores Rodríguez Garrido

Onderzoekers

  • Hoofdonderzoeker: MªDolores Rodriguez, diploma, ICS

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 mei 2021

Primaire voltooiing (Werkelijk)

31 augustus 2022

Studie voltooiing (Verwacht)

30 april 2023

Studieregistratiedata

Eerst ingediend

12 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2021

Eerst geplaatst (Werkelijk)

21 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2022

Laatste update ingediend die voldeed aan QC-criteria

30 augustus 2022

Laatst geverifieerd

1 augustus 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 4R16/146

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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