Impact of Telehealth Education in Diabetes Patients

NCT ID: NCT05696015

Last Updated: 2023-01-30

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2025-12-30

Brief Summary

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The goal of this clinical trial is to to evaluate the effectiveness of continuity of in-hospital care with the application of a structured telemonitoring protocol in self-care activities in patients with type 1 or type 2 Diabetes Mellitus or those who have an HbA1C level greater than or equal to 6.5% during hospitalization, regardless of the reason for hospitalization. The main question\[s\] it aims to answer are:

• Is telehealth education effective for improving self-care for type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization will be included, regardless of the reason for hospitalization? Participants will answer the Diabetes Self-Care Activity Questionnaire Researchers will compare patients in the intervention group, in addition to the hospital's standard hospital guidance, will receive an educational approach through structured telemonitoring, reinforcing and validating the points addressed in the face-to-face guidance, which are considered the foundations of self-care.

Detailed Description

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This study have two groups of patients. Group 1 will be carried out at discharge, discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD). For this group, a new contact will be made within 30 days after discharge, where the QAD will be applied again.

Group 2 will be performed at the time of discharge, guidance for discharge of patients with diabetes. This group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. At the time of discharge, and in the third contact, 30 days, the QAD will also be applied.

Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomized clinical trial.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Patients will be randomized using the Randomizer software into a group that will receive the telemonitoring intervention and a control group (which will only receive the hospital's standard hospital discharge instructions).

Study Groups

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Standard education

Standard education group will be carried out at discharge, discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD). For this group, a new contact will be made within 30 days after discharge, where the QAD will be applied again.

Group Type ACTIVE_COMPARATOR

Standard education

Intervention Type BEHAVIORAL

Without telehealth education, this group has only postdischarge education.

Amplied education

Amplied education group will be performed at the time of discharge, guidance for discharge of patients with diabetes. This group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. At the time of discharge, and in the third contact, 30 days, the QAD will also be applied.

Group Type EXPERIMENTAL

Ampiled Education

Intervention Type BEHAVIORAL

With telehealth education, in addition of discharge education.

Interventions

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Standard education

Without telehealth education, this group has only postdischarge education.

Intervention Type BEHAVIORAL

Ampiled Education

With telehealth education, in addition of discharge education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients who were hospitalized at Hospital Israelita Albert Einstein and included in the subcutaneous insulin protocol to control hyperglycemia
* patients monitored by the Diabetes Program, an institutional program that manages glycemic changes that occur within the institution.
* patients with type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization.

Exclusion Criteria

* Patients not submitted to the first face-to-face educational approach required by protocol
* Patients discharged on the weekend or holidays
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Simone Brandi

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Simone Brandi, MS

Role: CONTACT

5511971505024

Tatianna Pinheiro Rozzino, MD

Role: CONTACT

5511981425691

References

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Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Educ Couns. 2016 Jun;99(6):926-43. doi: 10.1016/j.pec.2015.11.003. Epub 2015 Nov 22.

Reference Type BACKGROUND
PMID: 26658704 (View on PubMed)

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.

Reference Type RESULT
PMID: 10895844 (View on PubMed)

Dong Y, Wang P, Dai Z, Liu K, Jin Y, Li A, Wang S, Zheng J. Increased self-care activities and glycemic control rate in relation to health education via Wechat among diabetes patients: A randomized clinical trial. Medicine (Baltimore). 2018 Dec;97(50):e13632. doi: 10.1097/MD.0000000000013632.

Reference Type RESULT
PMID: 30558051 (View on PubMed)

Ansari RM, Harris MF, Hosseinzadeh H, Zwar N. The Summary of an Urdu Version of Diabetes Self-Care Activities Measure: Psychometric Evaluation and Validation. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720935292. doi: 10.1177/2150132720935292.

Reference Type RESULT
PMID: 32538255 (View on PubMed)

Frosch DL, Uy V, Ochoa S, Mangione CM. Evaluation of a behavior support intervention for patients with poorly controlled diabetes. Arch Intern Med. 2011 Dec 12;171(22):2011-7. doi: 10.1001/archinternmed.2011.497. Epub 2011 Oct 10.

Reference Type RESULT
PMID: 21986347 (View on PubMed)

Weinger K, Beverly EA, Smaldone A. Diabetes self-care and the older adult. West J Nurs Res. 2014 Oct;36(9):1272-98. doi: 10.1177/0193945914521696. Epub 2014 Feb 7.

Reference Type RESULT
PMID: 24510969 (View on PubMed)

Whitehouse CR, Long JA, Maloney LM, Daniels K, Horowitz DA, Bowles KH. Feasibility of Diabetes Self-Management Telehealth Education for Older Adults During Transitions in Care. Res Gerontol Nurs. 2020 May 1;13(3):138-145. doi: 10.3928/19404921-20191210-03. Epub 2019 Dec 13.

Reference Type RESULT
PMID: 31834415 (View on PubMed)

Ose D, Kamradt M, Kiel M, Freund T, Besier W, Mayer M, Krisam J, Wensing M, Salize HJ, Szecsenyi J. Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial. PLoS One. 2019 Jun 12;14(6):e0214056. doi: 10.1371/journal.pone.0214056. eCollection 2019.

Reference Type RESULT
PMID: 31188825 (View on PubMed)

So CF, Chung JW. Telehealth for diabetes self-management in primary healthcare: A systematic review and meta-analysis. J Telemed Telecare. 2018 Jun;24(5):356-364. doi: 10.1177/1357633X17700552. Epub 2017 May 2.

Reference Type RESULT
PMID: 28463033 (View on PubMed)

Other Identifiers

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61722122.8.0000.0071

Identifier Type: -

Identifier Source: org_study_id

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