Diabetes Mellitus, Type 2NCT05301855
Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut Main Hospital
An observational study of Diabetes Mellitus, Type 2 and Adherence, Medication, run by Assiut University at 1 site in Egypt.
Trial summary
Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries [1].DM leads to serious problems in heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Adherence, Medication
- How many people
- 417 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2022to Dec 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: This study will be conducted in Assiut University Hospital. The target population will include diabetic patients attending Diabetes Clinic in Assiut University Hospital. The clinic offers various services including clinician consultations, health education, medication dispensing, foot, and vision screening. The clinic is also responsible for treating and monitoring patients with diabetes. All patients who fulfill the inclusion criteria and presented to Diabetes Clinic in Assiut University Hospital will be included in the present study
Who may be able to join
- 1- Patients who are diagnosed with type 2 DM for at least 1 year according to the diagnostic criteria of the 10th revision of the International Classification of Diseases (ICD-10).
- 2- Patients treated with insulin or oral medication or both for at least 6 months.
- 3- Age group: adult patients (> 18 years old) will be included in the present study.
Who cannot join
- 1- Newly diagnosed diabetic patients or ill on the day of recruitment, or not taking any medications for type2 DM 2- Patients with type1 DM 3- Psychiatric patients or on anti-depressant treatment or using psychotropic drugs affecting their cognitive ability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut University Hospital
Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries [1].DM leads to serious problems in heart, blood vessels, kidney and nerves.The World Health Organization (WHO) had anticipated that DM is going tobecome the seventh most significant primary cause of death worldwide by theyear 2030 [2]
Read the detailed description
Diabetes mellitus (DM) is considered one of the oldest fast-growing public health problems. It's a chronic metabolic disorder characterized mainly by high level of glucose level, associated globally with increased morbidity and mortality particularly in developing countries [1].
DM leads to serious problems in heart, blood vessels, kidney and nerves. The World Health Organization (WHO) had anticipated that DM is going to become the seventh most significant primary cause of death worldwide by the year 2030 [2].
Main types of DM include type1 DM where the body stops making insulin, and type 2 DM which is more common, usually in adults when the body becomes resistant to insulin or doesn't make enough insulin [3].
Currently, 463 million persons suffer from diabetes worldwide. In addition, 55 million in Middle East and North Africa (MENA) Region suffer from diabetes, and it is estimated that by 2045 this will rise to 108 million according to the International Diabetes Federation (IDF) [4] Egypt is considered the ninth leading country in the world for the number of type 2 diabetes patients and its prevalence was nearly tripled over the last 2 decades, reaching 15.2% as nearly 8 million of adults suffer from type 2 DM, expecting to be doubled by 2045, urging the global community to recognize DM as one of the most important health challenges of the twenty first century [4].
Hence comes the importance of self-management in patients with type 2 DM in reducing complications from the disease and improving overall health outcomes. These important self-management behaviors include taking medications regularly, healthy diet, doing physical activities, quitting smoking, foot care and self-monitoring blood glucose level [5].
Adherence of patients with type 2 DM to medication is associated with better balanced glycemic control (HbA1c <7%), thus helping in reduction of microvascular and macrovascular complications [6].
Adherence to medication is mainly influenced by several factors such as demographic, socioeconomic, cultural, health system related factors, educational and personal factors such as patient's age, complexity of medication, side effects, cost, availability, accessibility and whether they're receiving emotional and social support from their families [7].
Mental representation of DM affect patients' coping behavior. Many patients lack the understanding of type 2 DM. Perception of the disease is important, it's not just about taking the prescribed medication, it's about the extent to which the patient follows medical instructions [8].
Studies have showed that illness perception and beliefs about medication by type 2 DM patients is commonly linked with their adherence to medication and in return better glycemic control [9].
Perception is about everything regarding the illness such as illness identity, time line of the disease, consequences, comorbid conditions, number of hospital admission, whether it can be controlled or not, and emotional response to being diabetic [10]. Beliefs in self-control and self-management over health will affect adherence to treatment regimens and glycemic control [9].
Perception about illness shapes self-management behavior. If patients have strong perception about treatment plan and regimen with personal control, it'll lead to lower level of HbA1c and better health outcome [10].
Patients' beliefs about medication are mainly about the necessity of taking the prescribed medication to maintain their health now and in the future, and concerns about the possible negative effects of taking the medication such as addiction or long-term adverse effects from regular use. Some patients believe that medication helps them, while others believe that multiple harmful effects of the treatment may outweigh any positive outcomes. Some of the patients who have strong opinions about their medication avoid taking it or, conversely, abuse it [11].
Patients who are convinced that a specific medication is essential for their health are much more likely to adhere to the treatment than those who do not hold such a belief [12].
We hypothesize that some factors associated with non-adherence to medication can be investigated so that interventions can be implemented to increase adherence to medication, helping in achieving better glycemic control and better health outcomes and reducing complications.
As data concerning diabetic patients' adherence are deficient in upper Egypt, this study will help in filling the gap on illness perception and beliefs about medication, which in turn affects patients' adherence to medication and thus better glycemic control in type 2 DM.
- Conditions
- Diabetes Mellitus, Type 2, Adherence, Medication
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts:
The first part will inquire about sociodemographic data such as age, sex, educational level, occupation, residence, and marital status.
Measured: 2 years
The second part is about clinical data
The second part is about clinical data including BMI, duration of diabetes, type and number of prescribed medications, number of comorbid conditions, number of diabetes-related complications, and patients' most recent HbA1c levels were taken from medical records. HbA1c levels of ≥ 8% indicate suboptimal glycemic control in patients with T2D.
Measured: 2 years
The third part of the questionnaire is the Arabic version of Morisky Medication Adherence Scale (MMAS-8)
It remains one of the most widely used mechanisms to assess patient adherence . It consists of 8 questions. Response choices are "yes" or "no" for items 1 through 7 and Item 8 has a five-point Likert response scale. Each "no" response is rated as 1 and each "yes" response is rated as 0 except for item 5, in which each "yes" response is rated as 1 and each "no" response is rated as 0. For Item 8, the code (0-4) must be standardized by dividing the result by 4 to calculate a summated score . Total scores on the MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence
Measured: 2 years
The fourth part of the questionnaire is the Brief Illness Perception Questionnaire (B-IPQ).
B-IPQ is a rapid assessment tool with a Cronbach's alpha of 0.65 that measures eight different aspects of illness perception: consequences, timeline, personal control, treatment control, identity, concerns, understanding, and emotional representation [15]. The B-IPQ is a 9-item instrument that measures illness perception from eight different aspects using an 11-point Likert scale. A higher score reflects a more threatening view of the illness, while a lower score indicates a benign view of the illness
Measured: 2 years
The fifth part of the questionnaire is the Beliefs about medicine which is assessed using the Arabic version of the Beliefs about Medicines Questionnaire Specific (BMQ-Specific).
It includes two subscales, which evaluate patients' perceptions of the necessity of medicine in controlling their illness (Necessity-Specific) and concerns about potential adverse effects of medicine (Concerns-Specific). Each subscale consists of 5 items and is scored on a 5-point Likert scale. High scores on the Necessity-Specific subscale indicate that the patient perceives their medicine as necessary, whereas high scores on the Concerns-Specific subscale indicate that the patient is concerned about potential adverse effects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Galal Eldeen Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301855
- Sponsor's protocol ID
- Adherence to medication in DM
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reba K, Argaw Z, Walle B, Gutema H. Health-related quality of life of patients with diagnosed type 2 diabetes in Felege Hiwot Referral Hospital, North West Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Aug 2;11(1):544. doi: 10.1186/s13104-018-3625-x.
PubMed 30068392Ali M, Alemu T, Sada O. Medication adherence and its associated factors among diabetic patients at Zewditu Memorial Hospital, Addis Ababa, Ethiopia. BMC Res Notes. 2017 Dec 4;10(1):676. doi: 10.1186/s13104-017-3025-7.
PubMed 29202857Robert AA, Al Dawish MA. The Worrying Trend of Diabetes Mellitus in Saudi Arabia: An Urgent Call to Action. Curr Diabetes Rev. 2020;16(3):204-210. doi: 10.2174/1573399815666190531093735.
PubMed 31146665Olorunfemi O, Ojewole F. Medication belief as correlate of medication adherence among patients with diabetes in Edo State, Nigeria. Nurs Open. 2018 Sep 14;6(1):197-202. doi: 10.1002/nop2.199. eCollection 2019 Jan.
PubMed 30534409
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05301855
- Acronym / sponsor ID
- Adherence to medication in DM
- Conditions
- Diabetes Mellitus, Type 2, Adherence, Medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Mar 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.
Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries [1].DM leads to serious problems in heart, blood vessels, kidney and nerves.The World Health Organization (WHO) had anticipated that DM is going tobecome the seventh most significant primary cause of death worldwide by theyear 2030 [2]
Detailed description
Diabetes mellitus (DM) is considered one of the oldest fast-growing public health problems. It's a chronic metabolic disorder characterized mainly by high level of glucose level, associated globally with increased morbidity and mortality particularly in developing countries [1].
DM leads to serious problems in heart, blood vessels, kidney and nerves. The World Health Organization (WHO) had anticipated that DM is going to become the seventh most significant primary cause of death worldwide by the year 2030 [2].
Main types of DM include type1 DM where the body stops making insulin, and type 2 DM which is more common, usually in adults when the body becomes resistant to insulin or doesn't make enough insulin [3].
Currently, 463 million persons suffer from diabetes worldwide. In addition, 55 million in Middle East and North Africa (MENA) Region suffer from diabetes, and it is estimated that by 2045 this will rise to 108 million according to the International Diabetes Federation (IDF) [4] Egypt is considered the ninth leading country in the world for the number of type 2 diabetes patients and its prevalence was nearly tripled over the last 2 decades, reaching 15.2% as nearly 8 million of adults suffer from type 2 DM, expecting to be doubled by 2045, urging the global community to recognize DM as one of the most important health challenges of the twenty first century [4].
Hence comes the importance of self-management in patients with type 2 DM in reducing complications from the disease and improving overall health outcomes. These important self-management behaviors include taking medications regularly, healthy diet, doing physical activities, quitting smoking, foot care and self-monitoring blood glucose level [5].
Adherence of patients with type 2 DM to medication is associated with better balanced glycemic control (HbA1c <7%), thus helping in reduction of microvascular and macrovascular complications [6].
Adherence to medication is mainly influenced by several factors such as demographic, socioeconomic, cultural, health system related factors, educational and personal factors such as patient's age, complexity of medication, side effects, cost, availability, accessibility and whether they're receiving emotional and social support from their families [7].
Mental representation of DM affect patients' coping behavior. Many patients lack the understanding of type 2 DM. Perception of the disease is important, it's not just about taking the prescribed medication, it's about the extent to which the patient follows medical instructions [8].
Studies have showed that illness perception and beliefs about medication by type 2 DM patients is commonly linked with their adherence to medication and in return better glycemic control [9].
Perception is about everything regarding the illness such as illness identity, time line of the disease, consequences, comorbid conditions, number of hospital admission, whether it can be controlled or not, and emotional response to being diabetic [10]. Beliefs in self-control and self-management over health will affect adherence to treatment regimens and glycemic control [9].
Perception about illness shapes self-management behavior. If patients have strong perception about treatment plan and regimen with personal control, it'll lead to lower level of HbA1c and better health outcome [10].
Patients' beliefs about medication are mainly about the necessity of taking the prescribed medication to maintain their health now and in the future, and concerns about the possible negative effects of taking the medication such as addiction or long-term adverse effects from regular use. Some patients believe that medication helps them, while others believe that multiple harmful effects of the treatment may outweigh any positive outcomes. Some of the patients who have strong opinions about their medication avoid taking it or, conversely, abuse it [11].
Patients who are convinced that a specific medication is essential for their health are much more likely to adhere to the treatment than those who do not hold such a belief [12].
We hypothesize that some factors associated with non-adherence to medication can be investigated so that interventions can be implemented to increase adherence to medication, helping in achieving better glycemic control and better health outcomes and reducing complications.
As data concerning diabetic patients' adherence are deficient in upper Egypt, this study will help in filling the gap on illness perception and beliefs about medication, which in turn affects patients' adherence to medication and thus better glycemic control in type 2 DM.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in Assiut University Hospital. The target population will include diabetic patients attending Diabetes Clinic in Assiut University Hospital. The clinic offers various services including clinician consultations, health education, medication dispensing, foot, and vision screening. The clinic is also responsible for treating and monitoring patients with diabetes. All patients who fulfill the inclusion criteria and presented to Diabetes Clinic in Assiut University Hospital will be included in the present study
Key inclusion criteria (3 listed)
- 1- Patients who are diagnosed with type 2 DM for at least 1 year according to the diagnostic criteria of the 10th revision of the International Classification of Diseases (ICD-10).
- 2- Patients treated with insulin or oral medication or both for at least 6 months.
- 3- Age group: adult patients (> 18 years old) will be included in the present study.
Key exclusion criteria (1 listed)
- 1- Newly diagnosed diabetic patients or ill on the day of recruitment, or not taking any medications for type2 DM 2- Patients with type1 DM 3- Psychiatric patients or on anti-depressant treatment or using psychotropic drugs affecting their cognitive ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts:
Time frame: 2 years
The first part will inquire about sociodemographic data such as age, sex, educational level, occupation, residence, and marital status.
The second part is about clinical data
Time frame: 2 years
The second part is about clinical data including BMI, duration of diabetes, type and number of prescribed medications, number of comorbid conditions, number of diabetes-related complications, and patients' most recent HbA1c levels were taken from medical records. HbA1c levels of ≥ 8% indicate suboptimal glycemic control in patients with T2D.
The third part of the questionnaire is the Arabic version of Morisky Medication Adherence Scale (MMAS-8)
Time frame: 2 years
It remains one of the most widely used mechanisms to assess patient adherence . It consists of 8 questions. Response choices are "yes" or "no" for items 1 through 7 and Item 8 has a five-point Likert response scale. Each "no" response is rated as 1 and each "yes" response is rated as 0 except for item 5, in which each "yes" response is rated as 1 and each "no" response is rated as 0. For Item 8, the code (0-4) must be standardized by dividing the result by 4 to calculate a summated score . Total scores on the MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence
The fourth part of the questionnaire is the Brief Illness Perception Questionnaire (B-IPQ).
Time frame: 2 years
B-IPQ is a rapid assessment tool with a Cronbach's alpha of 0.65 that measures eight different aspects of illness perception: consequences, timeline, personal control, treatment control, identity, concerns, understanding, and emotional representation [15]. The B-IPQ is a 9-item instrument that measures illness perception from eight different aspects using an 11-point Likert scale. A higher score reflects a more threatening view of the illness, while a lower score indicates a benign view of the illness
The fifth part of the questionnaire is the Beliefs about medicine which is assessed using the Arabic version of the Beliefs about Medicines Questionnaire Specific (BMQ-Specific).
Time frame: 2 years
It includes two subscales, which evaluate patients' perceptions of the necessity of medicine in controlling their illness (Necessity-Specific) and concerns about potential adverse effects of medicine (Concerns-Specific). Each subscale consists of 5 items and is scored on a 5-point Likert scale. High scores on the Necessity-Specific subscale indicate that the patient perceives their medicine as necessary, whereas high scores on the Concerns-Specific subscale indicate that the patient is concerned about potential adverse effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 30068392Reba K, Argaw Z, Walle B, Gutema H. Health-related quality of life of patients with diagnosed type 2 diabetes in Felege Hiwot Referral Hospital, North West Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Aug 2;11(1):544. doi: 10.1186/s13104-018-3625-x.
- Background: PubMed 29202857Ali M, Alemu T, Sada O. Medication adherence and its associated factors among diabetic patients at Zewditu Memorial Hospital, Addis Ababa, Ethiopia. BMC Res Notes. 2017 Dec 4;10(1):676. doi: 10.1186/s13104-017-3025-7.
- Background: PubMed 31146665Robert AA, Al Dawish MA. The Worrying Trend of Diabetes Mellitus in Saudi Arabia: An Urgent Call to Action. Curr Diabetes Rev. 2020;16(3):204-210. doi: 10.2174/1573399815666190531093735.
- Background: PubMed 30534409Olorunfemi O, Ojewole F. Medication belief as correlate of medication adherence among patients with diabetes in Edo State, Nigeria. Nurs Open. 2018 Sep 14;6(1):197-202. doi: 10.1002/nop2.199. eCollection 2019 Jan.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Adherence, Medication, run by Assiut University at 1 site in Egypt.
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 1 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 31 Mar 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 Egypt. 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?
Contact Zeinab G Abdelhamid, MD (01094838810, Zeinab_gatasalva@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts: (time frame: 2 years). The study lists 5 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 NCT05301855, which also lists 4 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 31 Mar 2022.