Diabete MellitusTPCDTNCT05380596
TelePharmaceutical Care Diabetes Trial
A study testing Telepharmaceutical Care in people with Diabete Mellitus and Diabete Type 2, run by Rio Grande do Sul State Health Department - SES/RS at 1 site in Brazil.
Trial summary
The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Diabete Type 2, Telemedicine
- What is being tested?
- Telepharmaceutical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2022to Jan 2023
- 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
- People aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the Special Medicines Pharmacy of the State of Rio Grande do Sul, Brazil, will be selected. In addition, it will be considered an inclusion criterion that the person is available to receive phone calls.
Who cannot join
- Do not present a telephone record registered in the system;
- Be participating in another diabetes education program;
- Pregnancy;
- Severe cognitive problems;
- Communication difficulties;
- Presence of other injuries;
- Patients who are hospitalized at the time of recruitment will also be excluded from participation in this study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rio Grande do Sul State Health Department - SES/RS
Porto Alegre, Rio Grande do Sul, 90110-150
Agnes ANG Nogueira Gossenheimer, Doctor, 55 51 32887922, agnes-gossenheimer@saude.rs.gov.br
Agnes ANG Nogueira Gossenheimer, Doctor
About this study
Official title: Impact of TelePharmaceutical Care on People With Type 2 Diabetes Melitus, Seen at the Special Medicines Pharmacy of the State of Rio Grande do Sul: a Randomized Clinical Trial (TelePharmaceutical Care Diabetes Trial)
The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.
- Conditions
- Diabete Mellitus, Diabete Type 2, Telemedicine, Telehealth
- Being tested
- Telepharmaceutical Care
- Keywords
- Telehealth, Pharmaceutical care, Diabetes mellitus, Pharmaceutical services, Tele-interventions
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepharmaceutical CareBehavioural
The intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3). In the opportunities, aspects related to pharmacotherapy and health status, non-pharmacological approaches, treatment adherence and evaluation of problems related to pharmacotherapy (PRM) will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group will remain out of contact with the research group and will receive usual care, which consists of receiving medications without additional information. After completion of the project, the control group will receive educational materials related to the care of people with diabetes and, if the effectiveness of the Pharmaceutical Telecare service is proven, this possibility of care will be offered to users. |
| Intervention | Active comparator | The intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3), via cell phone. Each consultation will address an aspect of health education for DM2. Receives: Behavioral: Telepharmaceutical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in HbA1c levels
The patient'S blood glucose level
Measured: 3 months
Adherence to treatment - Brief Medication Questionnaire (BMQ)
Assessment of treatment adherence through the BMQ.
Measured: 3 months
Secondary outcomes (9)
Adherence to treatment
Assessed by the Self-Care Inventory - revised (SCI-R).
Measured: 3 months
Variation in blood pressure levels
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Measured: 3 months
Variation in lipid profile
Will be obtained from medical records and laboratory tests that patients report at the beginning of tele calls.
Measured: 3 months
Hospitalizations
Number of hospitalizations in the period.
Measured: 3 months
Medical consultations
Number of medical consultations performed.
Measured: 3 months
Emergency visits
Number of emergency visits.
Measured: 3 months
Drug-related problems
Number of drug-related problems found and resolved.
Measured: 3 months
Service-related cost
Service-related cost
Measured: 3 months
Quality of life measured by DQOL-Brazil;
Quality of life measured by Diabetes Quality of Life Measure (DQOL-Brasil).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an unblinded randomized clinical trial comparing the outcomes between a group that will receive a Pharmaceutical Telecare intervention (pharmaceutical consultation via telephone), and the control group that will receive only the usual care. All steps of this study will follow the recommendations of the CONSORT guideline for clinical trials (SCHULZ, 2010)
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio Grande do Sul State Health Department - SES/RS
- Sponsor type
- Other government
- Collaborators
- Agnes Nogueira Gossenheimer, Ana Paula Rigo, Roberto Eduardo Schneiders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380596
- Sponsor's protocol ID
- RioGrandeSulSHD
- Acronym
- TPCDT
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of TelePharmaceutical Care on People With Type 2 Diabetes Melitus, Seen at the Special Medicines Pharmacy of the State of Rio Grande do Sul: a Randomized Clinical Trial (TelePharmaceutical Care Diabetes Trial)
- ClinicalTrials.gov ID
- NCT05380596
- Acronym / sponsor ID
- TPCDT / RioGrandeSulSHD
- Conditions
- Diabete Mellitus, Diabete Type 2, Telemedicine, Telehealth
- Keywords
- Telehealth, Pharmaceutical care, Diabetes mellitus, Pharmaceutical services, Tele-interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Rio Grande do Sul State Health Department - SES/RSOther government
- Collaborators
- Agnes Nogueira Gossenheimer, Ana Paula Rigo, Roberto Eduardo Schneiders
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 19 May 2022 (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 prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an unblinded randomized clinical trial comparing the outcomes between a group that will receive a Pharmaceutical Telecare intervention (pharmaceutical consultation via telephone), and the control group that will receive only the usual care. All steps of this study will follow the recommendations of the CONSORT guideline for clinical trials (SCHULZ, 2010)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will remain out of contact with the research group and will receive usual care, which consists of receiving medications without additional information. After completion of the project, the control group will receive educational materials related to the care of people with diabetes and, if the effectiveness of the Pharmaceutical Telecare service is proven, this possibility of care will be offered to users. |
| Intervention | Active comparator | Behavioral: Telepharmaceutical CareThe intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3), via cell phone. Each consultation will address an aspect of health education for DM2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People aged 18 years or older, with a previous diagnosis of type 2 diabetes mellitus and who take dapagliflozin at the Special Medicines Pharmacy of the State of Rio Grande do Sul, Brazil, will be selected. In addition, it will be considered an inclusion criterion that the person is available to receive phone calls.
Key exclusion criteria (7 listed)
- Do not present a telephone record registered in the system;
- Be participating in another diabetes education program;
- Pregnancy;
- Severe cognitive problems;
- Communication difficulties;
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 |
|---|---|---|
| Telepharmaceutical CareThe intervention will be carried out through three teleconsultations, one per month, with a pharmacist (Times 0, 1, 2 and 3). In the opportunities, aspects related to pharmacotherapy and health status, non-pharmacological approaches, treatment adherence and evaluation of problems related to pharmacotherapy (PRM) will be discussed. | Behavioural | Intervention |
Primary outcome
Variation in HbA1c levels
Time frame: 3 months
The patient'S blood glucose level
Adherence to treatment - Brief Medication Questionnaire (BMQ)
Time frame: 3 months
Assessment of treatment adherence through the BMQ.
9 secondary outcomes
Adherence to treatment
Time frame: 3 months
Variation in blood pressure levels
Time frame: 3 months
Variation in lipid profile
Time frame: 3 months
Hospitalizations
Time frame: 3 months
Medical consultations
Time frame: 3 months
Emergency visits
Time frame: 3 months
Drug-related problems
Time frame: 3 months
Service-related cost
Time frame: 3 months
Quality of life measured by DQOL-Brazil;
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- 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.
Rio Grande do Sul State Health Department - SES/RS
Porto Alegre, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepharmaceutical Care in people with Diabete Mellitus and Diabete Type 2, run by Rio Grande do Sul State Health Department - SES/RS at 1 site in Brazil.
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 1 inclusion and 7 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in HbA1c levels (time frame: 3 months). 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?
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 19 May 2022.