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| ID | Type | Description | Link |
|---|---|---|---|
| 084/24/SoP | Other Identifier | Addis Ababa University |
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| Name | Class |
|---|---|
| Mekelle University | OTHER |
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The goal of this interventional study is to learn about the effect of a peer support group intervention on adherence, self-care practice, and knowledge among diabetic patients on follow-up care. The main question it aims to answer is:
BACKGROUND Diabetes mellitus (DM) is a chronic metabolic disorder that comes as one of the fastest-growing global health challenges, with the number of affected individuals projected to reach 643 million by 2030 and 783 million by 2045. Sub-Saharan Africa is experiencing a rapid rise in DM prevalence, partly due to urbanization, lifestyle changes, and limited access to preventive and treatment services. In Ethiopia, diabetes contributes substantially to the burden of non-communicable diseases, yet many patients fail to achieve optimal glycemic control.
Peer support is considered a promising, feasible, and culturally appropriate enhancement to diabetes care, enabling participants to assist one another in their ongoing self-management efforts. It is effective in preventing the complications of diabetes and enhancing health outcomes in patients with diabetes. Previous systematic reviews have reported that programs were effective for diabetes outcomes, including glycemic control, knowledge of diabetes, self-management skills, and self-efficacy. A healthy lifestyle, an appropriate diet, and medication adherence among diabetic patients are essential factors in the prevention of diabetes complications as well as maintaining good glycemic control. However, many patients with diabetes fail to manage the disease due to its complex nature. Hence, patients with diabetes need self-management education to assist them in comprehending and dealing with the disease.
Several rigorous reviews have demonstrated that adherence to treatment among patients with chronic diseases in developed countries is about 50%. Considering the scarcity and inequities in access to healthcare services in developing countries, this rate is assumed to be even lower. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. Numerous studies suggested that diabetic peer support programs have positive outcomes on improvement of adherence to medication which is essential for successful diabetes management. For example, Shiyanbola and coworker supported that conduction of an efficacy trial to address medication adherence using a peer-supported tailored intervention is essential. The healthcare effectiveness report from united states (US) point out that inadequate medication adherence is one of the main causes of the differences in glycemic control attainment rates between real-world settings and randomized controlled trials, which emphasizes the need for better provider and patient support programs to improve adherence. Thus, Patient support programs can improve persistence with and/or adherence to medications for the treatment of chronic diseases like diabetes.
Sub-Saharan Africa researches have demonstrated that peer support programs are beneficial and enable participants to modify their lifestyle and adhere to treatment. A study conducted in Uganda showed that improvements in eating habits, diastolic blood pressure, and glycosylated hemoglobin (HbA1c), after peer support program had carried out to diabetic patients and concluded that as it is a workable intervention to enhance diabetes care in health care settings. Additionally, diabetes peer support programs have been demonstrated to enhance patients' health-related behaviors, metabolic management, and quality of life in nations such as South Africa, and Cameroon. After the diabetes peer support program has positively impacted its members in Malawi, the researchers suggested that additional recruitment and ongoing training for peer supporters is necessary to reinforce and update management knowledge and skills. Besides, they concluded that it is a viable strategy for the non-communicable diseases unit within the Ministry of Health. In Ethiopia, fewer than 50% of diabetic individuals obtain proper diabetes care.
Despite the empirical studies showing positive and significant relationships between diabetes peer support and treatment adherence among patients with diabetes, the exact mechanism by which peer support affects patient adherence is not yet completely understood. Further research is needed to address how the differences in types of support, such as functional or emotional support, are linked to outcomes for patients. Specifically, there remains a gap in understanding what constitutes peer support and how to effectively implement it in low-resource environments, like Ethiopia health care settings.
Patient education materials provided by diabetes focused organizations do not increase patient self efficacy or engagement with self management as these documents contain complex medical jargon and provide only general guidelines, not patient-specific instruction. Peer support interventions, where individuals with lived experience of diabetes share advice, encouragement, and practical strategies, offer a potentially powerful extension of these existing support systems. Such programs have demonstrated benefits in enhancing treatment adherence, self-care practices, and disease-related knowledge in various settings. Despite this, there is limited data from Ethiopia on the effect of structured peer support groups among patients receiving care in tertiary hospitals.
This study assesses the effectiveness of a structured peer support group in enhancing medication adherence, self-care behaviors, and diabetes-related knowledge among adult patients attending follow-up at ACSH, a tertiary care facility in northern Ethiopia. The findings aim to inform efforts to integrate peer support into routine diabetes care within similar low-resource environments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants receive peer-led support sessions in addition to usual diabetes care. |
|
| No-Intervention Comparator: Standard Care Alone(Control group) | No Intervention | Participants continue with routine follow-up and standard diabetes care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Diabetes Education on medication Adherence and self care | Behavioral | Lived-experience facilitation, goal setting, real-world problem solving, and ongoing peer accountability not provided in standard clinician-led education. Peer-led, group-based sessions emphasizing lived experiences, problem-solving, and mutual support. Participants meet regularly in small groups facilitated by trained peers with diabetes. Includes structured booster follow-ups and SMS reminders to reinforce adherence and self-care. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence Status | Medication adherence of each group was assessed through a mixed method using the Morisky Medication Adherence Scale (MMAS-8) and self-reported pill count. The Morisky Medication Adherence Scale consisted of seven dichotomous items and one item rated on a five-point Likert scale which provided five response options, scored from 0 to 1 in 0.25-point increments. Based on the total score, patients were classified as low adherers (score <6), medium adherers (score 6 to <8),or high adherers (score = 8). | Baseline and 6 months |
| Overall Diabetes Self-Care Practice Score | Overall diabetes self-care practice was assessed using a standardized self-care questionnaire covering multiple domains, including general diet, specific diet, physical activity, blood glucose monitoring, foot care, and adherence to health care provider recommendations. A composite self-care practice score was calculated and participants were categorized as having good self care practice if a mean scored of 3.5 and greater days per week and poor self-care practice if mean scored less than 3.5days per week.The higher scores mean a better outcome. | Baseline and 6 months |
| Diabetes Knowledge Status | Diabetes-related knowledge was assessed using a validated instrument designed to measure patients' knowledge related to diabetes management. The questionnaire included 14 core items administered to all participants. An additional 9 items were administered to insulin users, resulting in a total possible score ranging from minimum(0)to Maximum score (14) for non-insulin users and minimum(0) to maximum(23) for insulin users. Each correct response was assigned one point, and item scores were summed to generate a total diabetes knowledge score. Higher scores indicate better diabetes-related knowledge. For interpretation, participants scoring at least 50% of the maximum possible score for their respective category (≥7 for non-insulin users and ≥11.5 for insulin users) were classified as having good diabetes-related knowledge, while those scoring less than 50% were classified as having poor diabetes-related knowledge.T | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence Status by Pill Count | Pill count data were obtained at each assessment round to evaluate actual medication use. Adherence was calculated by subtracting the number of pills remaining from the quantity dispensed, dividing the result by the product of the prescribed daily dose and the number of days since the last refill, and then multiplying by 100 to obtain a percentage. Patients with adherence below 80% were classified as poor adhrence, and those with above 80% were classified as good adhrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halefom K Haile, Msc | Addis Ababa University, Adigrat university | Principal Investigator |
| Teferi G Fenta, Professor | Addis Ababa University | Study Chair |
| Bruck M Habte, PhD | Addis Ababa University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayder Comprehensive Specialized Hospital (Mekelle University Hospital) | Mek'ele | Tigray | 86 | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35914061 | Background | Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/ | |
| 28688818 | Background | Atun R, Davies JI, Gale EAM, Barnighausen T, Beran D, Kengne AP, Levitt NS, Mangugu FW, Nyirenda MJ, Ogle GD, Ramaiya K, Sewankambo NK, Sobngwi E, Tesfaye S, Yudkin JS, Basu S, Bommer C, Heesemann E, Manne-Goehler J, Postolovska I, Sagalova V, Vollmer S, Abbas ZG, Ammon B, Angamo MT, Annamreddi A, Awasthi A, Besancon S, Bhadriraju S, Binagwaho A, Burgess PI, Burton MJ, Chai J, Chilunga FP, Chipendo P, Conn A, Joel DR, Eagan AW, Gishoma C, Ho J, Jong S, Kakarmath SS, Khan Y, Kharel R, Kyle MA, Lee SC, Lichtman A, Malm CP, Mbaye MN, Muhimpundu MA, Mwagomba BM, Mwangi KJ, Nair M, Niyonsenga SP, Njuguna B, Okafor OLO, Okunade O, Park PH, Pastakia SD, Pekny C, Reja A, Rotimi CN, Rwunganira S, Sando D, Sarriera G, Sharma A, Sidibe A, Siraj ES, Syed AS, Van Acker K, Werfalli M. Diabetes in sub-Saharan Africa: from clinical care to health policy. Lancet Diabetes Endocrinol. 2017 Aug;5(8):622-667. doi: 10.1016/S2213-8587(17)30181-X. Epub 2017 Jul 5. No abstract available. |
| Label | URL |
|---|---|
| World Health Organization. Adherence to long-term therapies: evidence for action. | View source |
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Currently, our data needs clearance,organization and documentation
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The study was conducted in two phases. Phase 1 was a preparatory phase conducted prior to participant enrollment and randomization. Phase 1 involved the recruitment and training of peer supporters (n = 5) and one registered nurse facilitator to support the delivery of the intervention. Individuals involved in Phase 1 were not trial participants, were not enrolled under the randomized clinical trial protocol, and did not contribute data to participant flow, baseline characteristics, outcome measu
The study was conducted in two phases. Phase I was a preparatory phase involving recruitment and training of peer supporters and a nurse facilitator for intervention delivery. No trial participants were enrolled in Phase I. Phase II involved enrollment and randomization of eligible diabetic patients into intervention and control groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants receive peer-led support sessions in addition to usual diabetes care. Structured Diabetes Education on medication Adherence and self care: Lived-experience facilitation, goal setting, real-world problem solving, and ongoing peer accountability not provided in standard clinician-led education. Peer-led, group-based sessions emphasizing lived experiences, problem-solving, and mutual support. Participants meet regularly in small groups facilitated by trained peers with diabetes. Includes structured booster follow-ups and SMS reminders to reinforce adherence and self-care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2025 |
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| Baseline and 6 months |
| 31454396 | Background | Gebreyohannes EA, Netere AK, Belachew SA. Glycemic control among diabetic patients in Ethiopia: A systematic review and meta-analysis. PLoS One. 2019 Aug 27;14(8):e0221790. doi: 10.1371/journal.pone.0221790. eCollection 2019. |
| 28702258 | Background | Fisher EB, Boothroyd RI, Elstad EA, Hays L, Henes A, Maslow GR, Velicer C. Peer support of complex health behaviors in prevention and disease management with special reference to diabetes: systematic reviews. Clin Diabetes Endocrinol. 2017 May 25;3:4. doi: 10.1186/s40842-017-0042-3. eCollection 2017. |
| 19509083 | Background | Funnell MM. Peer-based behavioural strategies to improve chronic disease self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Fam Pract. 2010 Jun;27 Suppl 1(Suppl 1):i17-22. doi: 10.1093/fampra/cmp027. Epub 2009 Jun 9. |
| 34696569 | Background | Azmiardi A, Murti B, Febrinasari RP, Tamtomo DG. The effect of peer support in diabetes self-management education on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis. Epidemiol Health. 2021;43:e2021090. doi: 10.4178/epih.e2021090. Epub 2021 Oct 22. |
| 30569831 | Background | Gutierrez AP, Fortmann AL, Savin K, Clark TL, Gallo LC. Effectiveness of Diabetes Self-Management Education Programs for US Latinos at Improving Emotional Distress: A Systematic Review. Diabetes Educ. 2019 Feb;45(1):13-33. doi: 10.1177/0145721718819451. Epub 2018 Dec 20. |
| 29357380 | Background | Debussche X, Besancon S, Balcou-Debussche M, Ferdynus C, Delisle H, Huiart L, Sidibe AT. Structured peer-led diabetes self-management and support in a low-income country: The ST2EP randomised controlled trial in Mali. PLoS One. 2018 Jan 22;13(1):e0191262. doi: 10.1371/journal.pone.0191262. eCollection 2018. |
| 32858474 | Background | Khare J, Jindal S. Observational study on Effect of Lock Down due to COVID 19 on glycemic control in patients with Diabetes: Experience from Central India. Diabetes Metab Syndr. 2020 Nov-Dec;14(6):1571-1574. doi: 10.1016/j.dsx.2020.08.012. Epub 2020 Aug 20. |
| 30652911 | Background | Lee AA, Piette JD, Heisler M, Janevic MR, Rosland AM. Diabetes self-management and glycemic control: The role of autonomy support from informal health supporters. Health Psychol. 2019 Feb;38(2):122-132. doi: 10.1037/hea0000710. |
| 36376960 | Background | Shiyanbola OO, Maurer M, Mott M, Schwerer L, Sarkarati N, Sharp LK, Ward E. A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans. Pilot Feasibility Stud. 2022 Nov 14;8(1):240. doi: 10.1186/s40814-022-01198-7. |
| 28801473 | Background | Edelman SV, Polonsky WH. Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control. Diabetes Care. 2017 Nov;40(11):1425-1432. doi: 10.2337/dc16-1974. Epub 2017 Aug 11. |
| 25792817 | Background | Burudpakdee C, Khan ZM, Gala S, Nanavaty M, Kaura S. Impact of patient programs on adherence and persistence in inflammatory and immunologic diseases: a meta-analysis. Patient Prefer Adherence. 2015 Mar 11;9:435-48. doi: 10.2147/PPA.S77053. eCollection 2015. |
| 16962622 | Background | Zachariah R, Teck R, Buhendwa L, Fitzerland M, Labana S, Chinji C, Humblet P, Harries AD. Community support is associated with better antiretroviral treatment outcomes in a resource-limited rural district in Malawi. Trans R Soc Trop Med Hyg. 2007 Jan;101(1):79-84. doi: 10.1016/j.trstmh.2006.05.010. Epub 2006 Sep 8. |
| 18453793 | Background | 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. |
| 9589228 | Result | Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706. |
| Book chapter on assessing diabetes self-management summary diabetes self-care activities questionnaire | View source |
| FG001 | No-Intervention Comparator: Standard Care Alone(Control Group) | Participants continue with routine follow-up and standard diabetes care only. |
| COMPLETED |
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| NOT COMPLETED |
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|
The study was conducted in two phases. Phase I was a preparatory phase involving recruitment and training of peer supporters and a nurse facilitator for intervention delivery. No trial participants were enrolled in Phase I. Phase II involved enrollment and randomization of eligible diabetic patients into intervention and control groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants receive peer-led support sessions in addition to usual diabetes care. Structured Diabetes Education on medication Adherence and self care: Lived-experience facilitation, goal setting, real-world problem solving, and ongoing peer accountability not provided in standard clinician-led education. Peer-led, group-based sessions emphasizing lived experiences, problem-solving, and mutual support. Participants meet regularly in small groups facilitated by trained peers with diabetes. Includes structured booster follow-ups and SMS reminders to reinforce adherence and self-care. |
| BG001 | No-Intervention Comparator: Standard Care Alone(Control Group) | Participants continue with routine follow-up and standard diabetes care only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Participants aged ≤18 years and ≥65 years were excluded based on the eligibility criteria; therefore, zero participants were enrolled in these age categories. | Baseline characteristics were collected only from Phase 2 randomized trial participants. No baseline data were collected from individuals involved in the Phase 1 preparatory activities. | Mean | Standard Deviation | years |
| |||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Type of Diabetes Mullituse | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Adherence Status | Medication adherence of each group was assessed through a mixed method using the Morisky Medication Adherence Scale (MMAS-8) and self-reported pill count. The Morisky Medication Adherence Scale consisted of seven dichotomous items and one item rated on a five-point Likert scale which provided five response options, scored from 0 to 1 in 0.25-point increments. Based on the total score, patients were classified as low adherers (score <6), medium adherers (score 6 to <8),or high adherers (score = 8). | Posted | Count of Participants | Participants | Baseline and 6 months |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Overall Diabetes Self-Care Practice Score | Overall diabetes self-care practice was assessed using a standardized self-care questionnaire covering multiple domains, including general diet, specific diet, physical activity, blood glucose monitoring, foot care, and adherence to health care provider recommendations. A composite self-care practice score was calculated and participants were categorized as having good self care practice if a mean scored of 3.5 and greater days per week and poor self-care practice if mean scored less than 3.5days per week.The higher scores mean a better outcome. | Posted | Mean | Standard Deviation | days/week | Baseline and 6 months |
| |||||||||||||||||||||||||||||||||
| Primary | Diabetes Knowledge Status | Diabetes-related knowledge was assessed using a validated instrument designed to measure patients' knowledge related to diabetes management. The questionnaire included 14 core items administered to all participants. An additional 9 items were administered to insulin users, resulting in a total possible score ranging from minimum(0)to Maximum score (14) for non-insulin users and minimum(0) to maximum(23) for insulin users. Each correct response was assigned one point, and item scores were summed to generate a total diabetes knowledge score. Higher scores indicate better diabetes-related knowledge. For interpretation, participants scoring at least 50% of the maximum possible score for their respective category (≥7 for non-insulin users and ≥11.5 for insulin users) were classified as having good diabetes-related knowledge, while those scoring less than 50% were classified as having poor diabetes-related knowledge.T | The number of participants analyzed varies by outcome measure due to eligibility criteria ( insulin useer vurese none insulin users).Row-level analyzed numbers are already reported. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 months |
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| Secondary | Medication Adherence Status by Pill Count | Pill count data were obtained at each assessment round to evaluate actual medication use. Adherence was calculated by subtracting the number of pills remaining from the quantity dispensed, dividing the result by the product of the prescribed daily dose and the number of days since the last refill, and then multiplying by 100 to obtain a percentage. Patients with adherence below 80% were classified as poor adhrence, and those with above 80% were classified as good adhrence. | The Outcome Measures were revised so that each assessment has a single unit of measure. Medication adherence assessed by MMAS-8 and pill count are now reported as separate Outcome Measures in accordance with registry requirements. | Posted | Count of Participants | Participants | Baseline and 6 months |
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from enrollment until the end of follow-up to 6 months
Non systematically assessed the group on loss to follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Adverse events were monitored throughout the study period during routine follow-up visits. No serious or non-serious adverse events related to the intervention were observed or reported in either study arm. | 0 | 50 | 0 | 50 | 2 | 50 |
| EG001 | No-Intervention Comparator: Standard Care Alone(Control Group) | Participants continue with routine follow-up and standard diabetes care only. | 0 | 50 | 0 | 50 | 1 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevation of Fast Blood Glucose(FBG) | Investigations | DKA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Halefom Kahsay Haile | Addis Ababa University | 914257964 | +251 | heleka94@gmail.com |
| Jan 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012648 | Self Care |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Between 18 and 65 years |
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| >=65 years |
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| Type 2 Diabetes Mullites(T2DM) |
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| Good Adherence |
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| Endline |
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| OG001 |
| No-Intervention Comparator: Standard Care Alone(Control Group) |
Participants in the control group received standard diabetes care alone during the follow-up period. |
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| OG001 | No-Intervention Comparator: Standard Care Alone(Control Group) | Participants in the control group received standard diabetes care alone during the follow-up period. |
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| OG001 |
| No-Intervention Comparator: Standard Care Alone(Control Group) |
Participants in the control group received standard diabetes care with in the diabtes center as well as collected their prescribed medications from the hospital pharmacy up on visiting the hospital for follow up with standard pharmaceutical care. |
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