Clinical trial NCT04932356: Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Educational Technology
Diabetes Mellitus Type 2
Glycated Hemoglobin A
Pragmatic Clinical Trial
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c Result
timeFrame: 7 months
Secondary outcomes:
measure: patient motivation
timeFrame: 6 month
Other outcomes:
Locations:
city: Viladecans
country: Spain
facility: MªDolores Rodriguez
state: Barcelona
Study officials:
affiliation: ICS
name: MªDolores Rodriguez, diploma
role: PRINCIPAL_INVESTIGATOR
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