Type 2 DiabetesNCT05202067
Impact of Pharmaceutical Education on Medication Adherence
A study testing pharmaceutical education in people with Type 2 Diabetes and Systemic Arterial Hypertension, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
Trial summary
Purpose. To evaluate the impact of pharmaceutical education in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension on their medication adherence. Material and research methods. Randomized clinical trial with a control group with a duration of 6 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Systemic Arterial Hypertension, Medication Adherence
- What is being tested?
- pharmaceutical education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2019to 30 Dec 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients cared for by the internal medicine outpatient area of the OPD Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca "
- 18-60 years
- Both genres
- With a diagnosis of type 2 diabetes mellitus and systemic arterial hypertension
- That they gave their consent under information
Who cannot join
- Inpatients on the day of their internal medicine outpatient appointment.
- Patients for whom pharmacological treatment was not prescribed for the treatment of DM2 and SAH.
- Patients who do not speak Spanish.
- Patients who could not or could not read.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital civil de Guadalajara "Dr. Juan I. Menchaca"
Guadalajara, Jalisco, 44340
About this study
Official title: Impact of Pharmaceutical Education on Medication Adherence in Patients With Type 2 Diabetes Mellitus and Systemic Arterial Hypertension Treated at the Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
Purpose. To evaluate the impact of pharmaceutical education in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension on their medication adherence.
Material and research methods. Randomized clinical trial with a control group with a duration of 6 months of follow-up. Patients with a diagnosis of Type 2 Diabetes Mellitus andWE Systemic Arterial Hypertension treated in the internal medicine outpatient of a school hospital will be included. Adherence to medication will be evaluated using Morisky's 8-item medication adherence scale.
The investigators believe that Pharmaceutical education increases therapeutic adherence in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
Read the detailed description
Patients and study design In this randomized and controlled clinical trial, patients will be assigned to two study groups: intervention group and control group; The patients will be followed for 6 months, considering evaluations at 0, 3 and 6 months.
To improve patient adherence to treatment, the investigators will provide a pocket card with an up-to-date list of the patient's prescribed medications along with recommendations for follow-up care. For the evaluation of adherence to treatment, © MMAS is used, it is authorized: MMAR, LLC., Donald E. Morisky # 6533-7069-1342-3041-5361, 294 Lindura Court, Las Vegas, Nevada 89138-4632.
Variables analyzed After randomization, the investigator will interview patients to obtain demographic data and their medical history. Data such as: time of evolution of the disease, number of prescribed medications, family support, cost of drug treatments will be collected, and the levels of glycosylated hemoglobin, fasting plasma glucose, cholesterol and triglycerides will be determined.
Medication adherence Adherence to medication will be evaluated using the Morisky method of 8 items, which is a validated indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale It is a generic scale to evaluate the patient's behavior regarding adherence to treatment, the points obtained with MMAS-8 are added to give a range of low, medium and high adherence scores. The total score is a sum of the 8 items and ranges between 0 and 8: values with a score greater than 8 reflect high adherence to medication, values between 6 and 7 reflect medium adherence and values below 6 reflect low adherence.
Sample size calculation A sample size calculation shows that a sample of 38 patients in each group is sufficient to find a difference in adherence to treatment with an alpha error of 0.05 and a power of 0.80 of the test, contemplating a 20% loss. The calculation was performed with the expected proportions formula.
Statistical analysis The investigators will report categorical variables as frequencies and percentages and analyzed with χ2 or Fisher's exact tests as necessary; quantitative variables will be presented as mean and standard deviation. The investigators will use the Wilcoxon test for intragroup comparisons and the Mann-Whitney U test for intergroup comparisons. The results will be considered significant at a two-sided p value of <0.05, with a 95% confidence interval. The statistical analyzes will be carried out using Statistical Solutions for Products and Services version 24.0.
- Being tested
- pharmaceutical education
- Keywords
- Pharmaceutical education, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Medication adherence
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical educationBehavioural
The patients who were assigned to the intervention group will receive a didactic talk from the research pharmacist. In addition, the patient will be given an updated list of their prescribed medications on a wallet card.
| Study group | Role | What they receive |
|---|---|---|
| pharmaceutical education | Experimental | The patients assigned to the intervention group will receive from the research pharmacist, a didactic talk (of at least 10 and up to 20 minutes), where they will be provided information about type 2 diabetes mellitus and Systemic Arterial Hypertension, causes of the disease and consequences of poor control, on its pharmacological treatments, changes in lifestyle and diet. In addition, the patient will be given an updated list of their prescribed medications on a wallet card. Receives: Behavioral: pharmaceutical education |
| control | No intervention | Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Measured: Basal
Medication adherence
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Measured: 3 months
Medication adherence
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients assigned to the intervention group will receive from the research pharmacist, a didactic talk (of at least 10 and up to 20 minutes), where they will be provided information about type 2 diabetes mellitus and Systemic Arterial Hypertension, causes of the disease and consequences of poor control, on its pharmacological treatments, changes in lifestyle and diet. In addition, the patient will be given an updated list of their prescribed medications on a wallet card. Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil Juan I. Menchaca
- Sponsor type
- University, hospital or other
- Collaborators
- Drake University
- Responsible party
- Principal investigator, Abelardo Contreras Vergara, Hospital Civil Juan I. Menchaca
- Investigators
- SELENE v HUERTA, PhD, Principal investigator, Universidad De Guadalajara (UDG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202067
- Sponsor's protocol ID
- 0269/18/HCJIM/01
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
PubMed 18453793
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmaceutical Education on Medication Adherence in Patients With Type 2 Diabetes Mellitus and Systemic Arterial Hypertension Treated at the Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
- ClinicalTrials.gov ID
- NCT05202067
- Acronym / sponsor ID
- 0269/18/HCJIM/01
- Keywords
- Pharmaceutical education, Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hospital Civil Juan I. MenchacaUniversity, hospital or other
- Collaborators
- Drake University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Jan 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.
Purpose. To evaluate the impact of pharmaceutical education in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension on their medication adherence.
Material and research methods. Randomized clinical trial with a control group with a duration of 6 months of follow-up. Patients with a diagnosis of Type 2 Diabetes Mellitus andWE Systemic Arterial Hypertension treated in the internal medicine outpatient of a school hospital will be included. Adherence to medication will be evaluated using Morisky's 8-item medication adherence scale.
The investigators believe that Pharmaceutical education increases therapeutic adherence in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.
Detailed description
Patients and study design In this randomized and controlled clinical trial, patients will be assigned to two study groups: intervention group and control group; The patients will be followed for 6 months, considering evaluations at 0, 3 and 6 months.
To improve patient adherence to treatment, the investigators will provide a pocket card with an up-to-date list of the patient's prescribed medications along with recommendations for follow-up care. For the evaluation of adherence to treatment, © MMAS is used, it is authorized: MMAR, LLC., Donald E. Morisky # 6533-7069-1342-3041-5361, 294 Lindura Court, Las Vegas, Nevada 89138-4632.
Variables analyzed After randomization, the investigator will interview patients to obtain demographic data and their medical history. Data such as: time of evolution of the disease, number of prescribed medications, family support, cost of drug treatments will be collected, and the levels of glycosylated hemoglobin, fasting plasma glucose, cholesterol and triglycerides will be determined.
Medication adherence Adherence to medication will be evaluated using the Morisky method of 8 items, which is a validated indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale It is a generic scale to evaluate the patient's behavior regarding adherence to treatment, the points obtained with MMAS-8 are added to give a range of low, medium and high adherence scores. The total score is a sum of the 8 items and ranges between 0 and 8: values with a score greater than 8 reflect high adherence to medication, values between 6 and 7 reflect medium adherence and values below 6 reflect low adherence.
Sample size calculation A sample size calculation shows that a sample of 38 patients in each group is sufficient to find a difference in adherence to treatment with an alpha error of 0.05 and a power of 0.80 of the test, contemplating a 20% loss. The calculation was performed with the expected proportions formula.
Statistical analysis The investigators will report categorical variables as frequencies and percentages and analyzed with χ2 or Fisher's exact tests as necessary; quantitative variables will be presented as mean and standard deviation. The investigators will use the Wilcoxon test for intragroup comparisons and the Mann-Whitney U test for intergroup comparisons. The results will be considered significant at a two-sided p value of <0.05, with a 95% confidence interval. The statistical analyzes will be carried out using Statistical Solutions for Products and Services version 24.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients assigned to the intervention group will receive from the research pharmacist, a didactic talk (of at least 10 and up to 20 minutes), where they will be provided information about type 2 diabetes mellitus and Systemic Arterial Hypertension, causes of the disease and consequences of poor control, on its pharmacological treatments, changes in lifestyle and diet. In addition, the patient will be given an updated list of their prescribed medications on a wallet card. Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician.
| Arm | Type | Receives |
|---|---|---|
| pharmaceutical education | Experimental | Behavioral: pharmaceutical educationThe patients assigned to the intervention group will receive from the research pharmacist, a didactic talk (of at least 10 and up to 20 minutes), where they will be provided information about type 2 diabetes mellitus and Systemic Arterial Hypertension, causes of the disease and consequences of poor control, on its pharmacological treatments, changes in lifestyle and diet. In addition, the patient will be given an updated list of their prescribed medications on a wallet card. |
| control | No intervention | –Patients assigned to the control group will receive only standard care, represented by regular consultation with their prescribing physician. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients cared for by the internal medicine outpatient area of the OPD Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca "
- 18-60 years
- Both genres
- With a diagnosis of type 2 diabetes mellitus and systemic arterial hypertension
- That they gave their consent under information
Key exclusion criteria (4 listed)
- Inpatients on the day of their internal medicine outpatient appointment.
- Patients for whom pharmacological treatment was not prescribed for the treatment of DM2 and SAH.
- Patients who do not speak Spanish.
- Patients who could not or could not read.
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 |
|---|---|---|
| pharmaceutical educationThe patients who were assigned to the intervention group will receive a didactic talk from the research pharmacist. In addition, the patient will be given an updated list of their prescribed medications on a wallet card. | Behavioural | pharmaceutical education |
Primary outcome
Medication adherence
Time frame: Basal
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Medication adherence
Time frame: 3 months
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Medication adherence
Time frame: 6 months
Adherence to medication will be evaluated using the Morisky method of 8 items, which is a valid indicator of non-compliance with medication in the treatment of chronic diseases, the Morisky Medication Adherence Scale is a generic scale to evaluate the behavior of the patient regarding adherence to treatment, the articles obtained with MMAS-8 are added to give a range of low, medium and high adherence scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Results publication: PubMed 18453793Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
- 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.
SELENE v HUERTA, PhD principal investigator
Universidad De Guadalajara (UDG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical education in people with Type 2 Diabetes and Systemic Arterial Hypertension, run by Hospital Civil Juan I. Menchaca at 1 site in Mexico.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Basal). The study lists 3 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 NCT05202067, which also lists 1 linked publication.
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 3 Feb 2022.