Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin LevelsHEWL-SMBNCT06189417
Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
A study testing Health Extension Led club based Intervention in people with Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels, run by Debre Berhan University at 1 site in Ethiopia.
Trial summary
Despite the existence of lifestyle interventions designed to encourage self-management behaviors, the difficulty of adhering to recommended practices remains a widespread issue globally, including in Ethiopia. Traditional approaches to care have demonstrated limited effectiveness in promoting self-management behavior. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels
- What is being tested?
- Health Extension Led club based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Feb 2024to 1 Feb 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes who have provided informed consent
- Patients with diabetes who do not have any other diabetes-related health complications at the start of the study
- Patients with diabetes who are not pregnant
- Patients with diabetes who have completed six months in the study
- Patients with diabetes who have expressed their intention to remain within the study facility (health post) and community.
Who cannot join
- Patients who decline to provide consent
- Patients who, based on medical assessment by their physician, are deemed unable to participate in the intervention
- Patients who choose not to continue with the intervention.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Debre Berhan University and North Shoa Zone Health Department
Debre Berhan, Amhara, 251
About this study
Despite the existence of lifestyle interventions designed to encourage self-management behaviors, the difficulty of adhering to recommended practices remains a widespread issue globally, including in Ethiopia. Traditional approaches to care have demonstrated limited effectiveness in promoting self-management behavior. As a potential solution, a Health Extension Worker-Led club-based intervention has been implemented. Therefore, the aim of this study is to assess the impact of the Health Extension Worker-Led club-based intervention on improving self-management behaviors and glycemic control.
The study will utilize a parallel-group, cluster randomized controlled trial design to investigate its objectives. The main focus of the research is to assess the average increase, both in terms of mean and percentage, in adherence to self-management behaviors and glycemic control. Additionally, the study aims to evaluating the acceptance of the intervention. To evaluate the impact of a Health Extension Worker-led intervention on self-management behavior and levels of glycosylated hemoglobin (HbA1C), a difference-in-difference analysis will be employed. A comparison of the intervention's effects across different groups will be conducted using an independent-sample t-test.
Read the detailed description
Despite the Ethiopian government's focus on non-communicable diseases, diabetes is increasingly becoming a major public health issue among adults. Unfortunately, diabetes care in numerous countries, including Ethiopia, is inadequate, resulting in undiagnosed cases, low rates of diabetes control, and failure to meet established care standards.
Insufficient readiness of healthcare services, inadequate training of healthcare professionals, and a lack of patient-centered interventions have contributed to inadequate healthcare coverage and suboptimal self-management behavior. The inadequate adherence to self-management behavior has become a critical issue, with half of the patients failing to comply in Ethiopia. Several systematic reviews and meta-analyses consistently indicate that the range for achieving good diabetes self-management behavior is between 49.8% and 51.12%.
To ensure the provision of high-quality diabetes care, it is vital to prioritize patient preferences and needs by adopting a patient-centered approach. The implementation of community-based care programs that prioritize patient-centeredness and aim to enhance patients' understanding of self-care management is of utmost importance. Published evidence strongly indicates that educational interventions can play a significant role in supporting individuals with diabetes to improve their self-care management.
The existing delivery approaches in various countries, including Ethiopia, are insufficient in facilitating the adoption of recommended self-care practices. Therefore, there is an urgent need to implement patient-centered care programs at the community level. To address this issue, a Health Extension Worker-Led club-based intervention has been introduced as a strategic intervention approach to fill this gap. The Health Extension Worker-led club-based intervention is seamlessly integrated into the existing Health Extension Program. The introduction of a community-based intervention has a significant impact on self-management behavior, improves access to chronic disease services, and enhances outcomes for individuals with chronic diseases.
To the best of our knowledge, there is a lack of evidence regarding the impact of a Health Extension Worker-led club based intervention on self-management behaviors in Ethiopia. Therefore, the objective of this study is to assess the impact of the Health Extension Worker (HEW)-led club-based intervention on improving self-management behaviors, glycemic control, and the acceptance of the intervention among individuals with diabetes in Ethiopia.
- Being tested
- Health Extension Led club based Intervention
- Keywords
- Health Extension Worker, Self-Management Behavior, Club Based Intervention, People with diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Extension Led club based InterventionBehavioural
The Health Extension Workers-led club-based intervention primarily focuses on equipping individuals with the necessary knowledge and skills to enhance their self-management behavior. The intervention encompasses education on adopting healthy eating habits, promoting regular exercise, effectively managing weight, and supporting smoking cessation. It emphasizes the importance of regular blood sugar level monitoring, limiting alcohol intake, and reducing sedentary behavior. The intervention also includes counseling to provide guidance and support in adopting and maintaining healthy behaviors. Additionally, it highlights the significance of adhering to medication regimens for optimal health outcomes. If additional medical attention is required, the intervention provides referral services to nearby health facilities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A total of 280 study participants are allocated to intervention group Receives: Behavioral: Health Extension Led club based Intervention |
| control group | No intervention | A total of 280 study participants are allocated to control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and proportion of diabetic self-management behavior
The proportion of self-management behaviors will be determined using the Diabetes Self-Care Activity Summary tool. Participants will be requested to report the frequency of these specific behaviors per week using an eight-point Likert scale, ranging from 0 to 7 days. The responses obtained through this scale will be utilized to compute an overall score, with higher average scores indicating greater adherence to self-management behaviors and practices. The study will compare the mean change in self-management behaviors at six months from baseline among the different groups.
Measured: measured at six months
Mean and proportion increase in glycemic control
Fasting blood sugar (FBS) and Glycosylated hemoglobin (HbA1C) are widely utilized measures to assess glycemic control. The baseline FBS analysis involves calculating the mean of FBS measurements taken over three consecutive months. During the follow-up period, the analysis is conducted using the mean values of FBS measurements taken over six consecutive months. According to the guideline recommendations of the American Diabetes Association (ADA), glycemic status is considered good if the mean FBS falls between 80 and 130 mg/dL. Glycosylated hemoglobin (HbA1C) levels will be assessed at two time points: three months during follow up and six months after the intervention. The optimal range for glycosylated hemoglobin (HbA1C) levels for individuals with diabetes is below 7% (53 mmol/mol).
Measured: measured at three and six months
Secondary outcomes (1)
Acceptability of a community-based club intervention led by Health Extension Workers
Acceptability, in this context, refers to the extent to which the intervention is perceived as appropriate, suitable, and desirable by the participating individuals. It assesses the community's willingness to actively engage with and adhere to the intervention, as well as their satisfaction and comfort with the intervention activities and delivery methods. To measure acceptability, participants will be asked to indicate their agreement with a series of statements related to the intervention using a five-point Likert scale, ranging from 1 to 5. The responses obtained through this scale will be utilized to compute an overall score, with higher average scores indicating greater acceptance level. Open-ended questions will also be included to gather participants' perspectives on the intervention content, their experiences with the HEW-led club intervention, and any suggestions for improvement.
Measured: measured at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin LevelsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon completion of the baseline data collection for both groups, a total of 28 clusters/villages will be selected, each involving a maximum of 20 study participants. These clusters will be evenly distributed, with 14 clusters assigned to the intervention group and 14 clusters allocated to the control group. The HEW-led club-based intervention will be integrated into the health extension package. The intervention will take place once a week during club meetings, lasting approximately 50 minutes for six months. Across all clusters or villages, the intervention group will receive 14 educational sessions within a week.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debre Berhan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Africa
- Responsible party
- Principal investigator, Akine Eshete, Debre Berhan University
- Investigators
- Akine E Abosetugn, MPH, Principal investigator, Debre Berhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189417
- Sponsor's protocol ID
- IRB-005/23
- Acronym
- HEWL-SMB
- Status last verified
- Aug 2024
- First submitted
- 7 Dec 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MoH., Realizing Universal Health Coverage through Primary Health Care: A Roadmap for Optimizing the Ethiopian Health Extension Program 2020 - 2035. Addis Ababa, Ethiopia: Ministry of Health, 2020. 2020.
Bishu K.G, et al., Diabetes in Ethiopia: A systematic review of prevalence, risk factors, complications, and cost. Obesity Medicine, 2019. 15: p. 100132:https://doi.org/10.1016/j.obmed.2019.100132.
Zeru MA, Tesfa E, Mitiku AA, Seyoum A, Bokoro TA. Prevalence and risk factors of type-2 diabetes mellitus in Ethiopia: systematic review and meta-analysis. Sci Rep. 2021 Nov 5;11(1):21733. doi: 10.1038/s41598-021-01256-9.
PubMed 34741064Mulugeta TK, Kassa DH. Readiness of the primary health care units and associated factors for the management of hypertension and type II diabetes mellitus in Sidama, Ethiopia. PeerJ. 2022 Aug 25;10:e13797. doi: 10.7717/peerj.13797. eCollection 2022.
PubMed 36042860Tesema AG, Peiris D, Abimbola S, Ajisegiri WS, Narasimhan P, Mulugeta A, Joshi R. Community health extension workers' training and supervision in Ethiopia: Exploring impact and implementation challenges for non-communicable disease service delivery. PLOS Glob Public Health. 2022 Nov 9;2(11):e0001160. doi: 10.1371/journal.pgph.0001160. eCollection 2022.
PubMed 36962619American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.
PubMed 33551551Dagnew B, Debalkie Demissie G, Abebaw Angaw D. Systematic Review and Meta-Analysis of Good Self-Care Practice among People Living with Type 2 Diabetes Mellitus in Ethiopia: A National Call to Bolster Lifestyle Changes. Evid Based Complement Alternat Med. 2021 Feb 20;2021:8896896. doi: 10.1155/2021/8896896. eCollection 2021.
PubMed 33688368Ansari R M, et al., Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis. Diabetology, 2022. 3(3): p. 407-422.
Ketema DB, Leshargie CT, Kibret GD, Assemie MA, Alamneh AA, Kassa GM, Alebel A. Level of self-care practice among diabetic patients in Ethiopia: a systematic review and meta-analysis. BMC Public Health. 2020 Mar 12;20(1):309. doi: 10.1186/s12889-020-8425-2.
PubMed 32164638FDREMoH, National Strategic Plan for the Prevention And Control Of Major Non-Communicable Diseases, 2013-2017(2020/21-2024/25), Addis Ababa Ethiopia; July 2020. 2020.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
- ClinicalTrials.gov ID
- NCT06189417
- Acronym / sponsor ID
- HEWL-SMB / IRB-005/23
- Keywords
- Health Extension Worker, Self-Management Behavior, Club Based Intervention, People with diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Debre Berhan UniversityUniversity, hospital or other
- Collaborators
- University of South Africa
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
Despite the existence of lifestyle interventions designed to encourage self-management behaviors, the difficulty of adhering to recommended practices remains a widespread issue globally, including in Ethiopia. Traditional approaches to care have demonstrated limited effectiveness in promoting self-management behavior. As a potential solution, a Health Extension Worker-Led club-based intervention has been implemented. Therefore, the aim of this study is to assess the impact of the Health Extension Worker-Led club-based intervention on improving self-management behaviors and glycemic control.
The study will utilize a parallel-group, cluster randomized controlled trial design to investigate its objectives. The main focus of the research is to assess the average increase, both in terms of mean and percentage, in adherence to self-management behaviors and glycemic control. Additionally, the study aims to evaluating the acceptance of the intervention. To evaluate the impact of a Health Extension Worker-led intervention on self-management behavior and levels of glycosylated hemoglobin (HbA1C), a difference-in-difference analysis will be employed. A comparison of the intervention's effects across different groups will be conducted using an independent-sample t-test.
Detailed description
Despite the Ethiopian government's focus on non-communicable diseases, diabetes is increasingly becoming a major public health issue among adults. Unfortunately, diabetes care in numerous countries, including Ethiopia, is inadequate, resulting in undiagnosed cases, low rates of diabetes control, and failure to meet established care standards.
Insufficient readiness of healthcare services, inadequate training of healthcare professionals, and a lack of patient-centered interventions have contributed to inadequate healthcare coverage and suboptimal self-management behavior. The inadequate adherence to self-management behavior has become a critical issue, with half of the patients failing to comply in Ethiopia. Several systematic reviews and meta-analyses consistently indicate that the range for achieving good diabetes self-management behavior is between 49.8% and 51.12%.
To ensure the provision of high-quality diabetes care, it is vital to prioritize patient preferences and needs by adopting a patient-centered approach. The implementation of community-based care programs that prioritize patient-centeredness and aim to enhance patients' understanding of self-care management is of utmost importance. Published evidence strongly indicates that educational interventions can play a significant role in supporting individuals with diabetes to improve their self-care management.
The existing delivery approaches in various countries, including Ethiopia, are insufficient in facilitating the adoption of recommended self-care practices. Therefore, there is an urgent need to implement patient-centered care programs at the community level. To address this issue, a Health Extension Worker-Led club-based intervention has been introduced as a strategic intervention approach to fill this gap. The Health Extension Worker-led club-based intervention is seamlessly integrated into the existing Health Extension Program. The introduction of a community-based intervention has a significant impact on self-management behavior, improves access to chronic disease services, and enhances outcomes for individuals with chronic diseases.
To the best of our knowledge, there is a lack of evidence regarding the impact of a Health Extension Worker-led club based intervention on self-management behaviors in Ethiopia. Therefore, the objective of this study is to assess the impact of the Health Extension Worker (HEW)-led club-based intervention on improving self-management behaviors, glycemic control, and the acceptance of the intervention among individuals with diabetes in Ethiopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Upon completion of the baseline data collection for both groups, a total of 28 clusters/villages will be selected, each involving a maximum of 20 study participants. These clusters will be evenly distributed, with 14 clusters assigned to the intervention group and 14 clusters allocated to the control group. The HEW-led club-based intervention will be integrated into the health extension package. The intervention will take place once a week during club meetings, lasting approximately 50 minutes for six months. Across all clusters or villages, the intervention group will receive 14 educational sessions within a week.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Extension Led club based InterventionA total of 280 study participants are allocated to intervention group |
| control group | No intervention | –A total of 280 study participants are allocated to control group |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diabetes who have provided informed consent
- Patients with diabetes who do not have any other diabetes-related health complications at the start of the study
- Patients with diabetes who are not pregnant
- Patients with diabetes who have completed six months in the study
- Patients with diabetes who have expressed their intention to remain within the study facility (health post) and community.
Key exclusion criteria (3 listed)
- Patients who decline to provide consent
- Patients who, based on medical assessment by their physician, are deemed unable to participate in the intervention
- Patients who choose not to continue with the intervention.
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 |
|---|---|---|
| Health Extension Led club based InterventionThe Health Extension Workers-led club-based intervention primarily focuses on equipping individuals with the necessary knowledge and skills to enhance their self-management behavior. The intervention encompasses education on adopting healthy eating habits, promoting regular exercise, effectively managing weight, and supporting smoking cessation. It emphasizes the importance of regular blood sugar level monitoring, limiting alcohol intake, and reducing sedentary behavior. The intervention also includes counseling to provide guidance and support in adopting and maintaining healthy behaviors. Additionally, it highlights the significance of adhering to medication regimens for optimal health outcomes. If additional medical attention is required, the intervention provides referral services to nearby health facilities. | Behavioural | Intervention Group |
Primary outcome
Mean and proportion of diabetic self-management behavior
Time frame: measured at six months
The proportion of self-management behaviors will be determined using the Diabetes Self-Care Activity Summary tool. Participants will be requested to report the frequency of these specific behaviors per week using an eight-point Likert scale, ranging from 0 to 7 days. The responses obtained through this scale will be utilized to compute an overall score, with higher average scores indicating greater adherence to self-management behaviors and practices. The study will compare the mean change in self-management behaviors at six months from baseline among the different groups.
Mean and proportion increase in glycemic control
Time frame: measured at three and six months
Fasting blood sugar (FBS) and Glycosylated hemoglobin (HbA1C) are widely utilized measures to assess glycemic control. The baseline FBS analysis involves calculating the mean of FBS measurements taken over three consecutive months. During the follow-up period, the analysis is conducted using the mean values of FBS measurements taken over six consecutive months. According to the guideline recommendations of the American Diabetes Association (ADA), glycemic status is considered good if the mean FBS falls between 80 and 130 mg/dL. Glycosylated hemoglobin (HbA1C) levels will be assessed at two time points: three months during follow up and six months after the intervention. The optimal range for glycosylated hemoglobin (HbA1C) levels for individuals with diabetes is below 7% (53 mmol/mol).
1 secondary outcome
Acceptability of a community-based club intervention led by Health Extension Workers
Time frame: measured at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- BackgroundMoH., Realizing Universal Health Coverage through Primary Health Care: A Roadmap for Optimizing the Ethiopian Health Extension Program 2020 - 2035. Addis Ababa, Ethiopia: Ministry of Health, 2020. 2020.
- BackgroundBishu K.G, et al., Diabetes in Ethiopia: A systematic review of prevalence, risk factors, complications, and cost. Obesity Medicine, 2019. 15: p. 100132:https://doi.org/10.1016/j.obmed.2019.100132.
- Background: PubMed 34741064Zeru MA, Tesfa E, Mitiku AA, Seyoum A, Bokoro TA. Prevalence and risk factors of type-2 diabetes mellitus in Ethiopia: systematic review and meta-analysis. Sci Rep. 2021 Nov 5;11(1):21733. doi: 10.1038/s41598-021-01256-9.
- Background: PubMed 36042860Mulugeta TK, Kassa DH. Readiness of the primary health care units and associated factors for the management of hypertension and type II diabetes mellitus in Sidama, Ethiopia. PeerJ. 2022 Aug 25;10:e13797. doi: 10.7717/peerj.13797. eCollection 2022.
- Background: PubMed 36962619Tesema AG, Peiris D, Abimbola S, Ajisegiri WS, Narasimhan P, Mulugeta A, Joshi R. Community health extension workers' training and supervision in Ethiopia: Exploring impact and implementation challenges for non-communicable disease service delivery. PLOS Glob Public Health. 2022 Nov 9;2(11):e0001160. doi: 10.1371/journal.pgph.0001160. eCollection 2022.
- Background: PubMed 33551551American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.
- Background: PubMed 33688368Dagnew B, Debalkie Demissie G, Abebaw Angaw D. Systematic Review and Meta-Analysis of Good Self-Care Practice among People Living with Type 2 Diabetes Mellitus in Ethiopia: A National Call to Bolster Lifestyle Changes. Evid Based Complement Alternat Med. 2021 Feb 20;2021:8896896. doi: 10.1155/2021/8896896. eCollection 2021.
- BackgroundAnsari R M, et al., Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis. Diabetology, 2022. 3(3): p. 407-422.
- Background: PubMed 32164638Ketema DB, Leshargie CT, Kibret GD, Assemie MA, Alamneh AA, Kassa GM, Alebel A. Level of self-care practice among diabetic patients in Ethiopia: a systematic review and meta-analysis. BMC Public Health. 2020 Mar 12;20(1):309. doi: 10.1186/s12889-020-8425-2.
- Results publicationFDREMoH, National Strategic Plan for the Prevention And Control Of Major Non-Communicable Diseases, 2013-2017(2020/21-2024/25), Addis Ababa Ethiopia; July 2020. 2020.
- Individual participant dataSharing planned: No
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.
Akine E Abosetugn, MPH principal investigator
Debre Berhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Extension Led club based Intervention in people with Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels, run by Debre Berhan University at 1 site in Ethiopia.
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 3 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 9 Aug 2024. 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 Ethiopia. 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?
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?
Mean and proportion of diabetic self-management behavior (time frame: measured at six 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?
On the ClinicalTrials.gov record for NCT06189417, which also lists 10 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 9 Aug 2024.