Diabetes Mellitus, Type 1NCT05696015
Impact of Telehealth Education in Diabetes Patients
A study testing Standard education and Ampiled Education in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Hospital Israelita Albert Einstein.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Standard education and Ampiled Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients not submitted to the first face-to-face educational approach required by protocol
- Patients discharged on the weekend or holidays
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Telehealth Education After Hospital Discharge on the Self-care of Patients With Diabetes
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.
Read the detailed description
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.
- Being tested
- Standard education, Ampiled Education
- Keywords
- self care
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard educationBehavioural
Without telehealth education, this group has only postdischarge education.
Ampiled EducationBehavioural
With telehealth education, in addition of discharge education.
| Study group | Role | What they receive |
|---|---|---|
| Standard education | Active comparator | 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. Receives: Behavioral: Standard education |
| Amplied education | Experimental | 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. Receives: Behavioral: Ampiled Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD) at 30 days follow-up. (Standard education)
The QAD instrument has six dimensions and 15 items for evaluating self-care with diabetes: "general diet" (two items), "specific diet" (three items), "physical activity" (two items) , "blood glucose monitoring" (two items), "foot care" (three items) and "medication use" (three items, used according to the medication regimen), in addition to three other items for the assessment of smoking . Patients answer how often (answers from 0 to 7) they performed the activities or behaviors in the seven days prior to completing the form.
For the calculation of scores, the items of the specific food dimension that ask about the consumption of foods high in fat and sweets, the values must be inverted (7=0, 6=1, 5=2, 4=3, 3=4 , 2=5, 1=6 and 0=7). Scores are calculated by averaging the items that make up each dimension, with zero being the least desirable situation and seven being the most favorable.
Measured: immediately pre and within 4 weeks post intervention
Change from baseline discharge telehealth orientation and application of the Diabetes Self-Care Activity Questionnaire (QAD) at within 72 hours after discharge, 10 days after and within 30 days after discharge
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. Contacts will be made via video call by trained health professionals, who will provide care based on a script structured by the authors, assessing adherence to self-care. The American Association of Diabetes Educators ( 7 Self-Care Behaviors ™) ) is a structured evidence-based tool that allows, in addition to self-care assessment, educational intervention in the seven topics covered, which include: 1) healthy eating, 2) physical activity, 3) glycemic monitoring , 4) medication use, 5) problem solving, 6) healthy coping, and 7) risk reduction.
Measured: immediately pre and within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start2 Mar 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Brandi, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696015
- Sponsor's protocol ID
- 61722122.8.0000.0071
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26658704Toobert 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.
PubMed 10895844Dong 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.
PubMed 30558051Ansari 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.
PubMed 32538255Frosch 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.
PubMed 21986347Weinger 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.
PubMed 24510969Whitehouse 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.
PubMed 31834415Ose 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.
PubMed 31188825So 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.
PubMed 28463033
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telehealth Education After Hospital Discharge on the Self-care of Patients With Diabetes
- ClinicalTrials.gov ID
- NCT05696015
- Acronym / sponsor ID
- 61722122.8.0000.0071
- Keywords
- self care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 2 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Standard education | Active comparator | Behavioral: Standard educationStandard 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. |
| Amplied education | Experimental | Behavioral: Ampiled EducationAmplied 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients not submitted to the first face-to-face educational approach required by protocol
- Patients discharged on the weekend or holidays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard educationWithout telehealth education, this group has only postdischarge education. | Behavioural | Standard education |
| Ampiled EducationWith telehealth education, in addition of discharge education. | Behavioural | Amplied education |
Primary outcome
Change from baseline discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD) at 30 days follow-up. (Standard education)
Time frame: immediately pre and within 4 weeks post intervention
The QAD instrument has six dimensions and 15 items for evaluating self-care with diabetes: "general diet" (two items), "specific diet" (three items), "physical activity" (two items) , "blood glucose monitoring" (two items), "foot care" (three items) and "medication use" (three items, used according to the medication regimen), in addition to three other items for the assessment of smoking . Patients answer how often (answers from 0 to 7) they performed the activities or behaviors in the seven days prior to completing the form. For the calculation of scores, the items of the specific food dimension that ask about the consumption of foods high in fat and sweets, the values must be inverted (7=0, 6=1, 5=2, 4=3, 3=4 , 2=5, 1=6 and 0=7). Scores are calculated by averaging the items that make up each dimension, with zero being the least desirable situation and seven being the most favorable.
Change from baseline discharge telehealth orientation and application of the Diabetes Self-Care Activity Questionnaire (QAD) at within 72 hours after discharge, 10 days after and within 30 days after discharge
Time frame: immediately pre and within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge
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. Contacts will be made via video call by trained health professionals, who will provide care based on a script structured by the authors, assessing adherence to self-care. The American Association of Diabetes Educators ( 7 Self-Care Behaviors ™) ) is a structured evidence-based tool that allows, in addition to self-care assessment, educational intervention in the seven topics covered, which include: 1) healthy eating, 2) physical activity, 3) glycemic monitoring , 4) medication use, 5) problem solving, 6) healthy coping, and 7) risk reduction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 26658704Chrvala 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.
- Results publication: PubMed 10895844Toobert 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.
- Results publication: PubMed 30558051Dong 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.
- Results publication: PubMed 32538255Ansari 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.
- Results publication: PubMed 21986347Frosch 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.
- Results publication: PubMed 24510969Weinger 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.
- Results publication: PubMed 31834415Whitehouse 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.
- Results publication: PubMed 31188825Ose 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.
- Results publication: PubMed 28463033So 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Standard education and Ampiled Education in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Hospital Israelita Albert Einstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Brandi, MS (5511971505024, simone.brandi@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD) at 30 days follow-up. (Standard education) (time frame: immediately pre and within 4 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696015, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.