Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia

NCT06189417 | Enrolling By Invitation

• 1 other identifier: IRB-005/23
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels

Keywords

Health Extension Worker, Self-Management Behavior, Club Based Intervention, People with diabetes

Outcome Measures

Primary Outcomes (2)

• 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 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 at three and six months

Secondary Outcomes (1)

• Acceptability of a community-based club intervention led by Health Extension Workers

  measured at six months

Study Arms (2)

Intervention Group

EXPERIMENTAL

A total of 280 study participants are allocated to intervention group

Behavioral: Health Extension Led club based Intervention

control group

NO INTERVENTION

A total of 280 study participants are allocated to control group

Interventions

Health Extension Led club based Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debre Berhan University: lead
• University of South Africa: collaborator

Study Sites (1)

Debre Berhan University and North Shoa Zone Health Department

Debre Berhan, Amhara, 251, Ethiopia

Location

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34741064 BACKGROUND

• Mulugeta 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.

  PMID: 36042860 BACKGROUND

• Tesema 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.

  PMID: 36962619 BACKGROUND

• American 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.

  PMID: 33551551 BACKGROUND

• Dagnew 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.

  PMID: 33688368 BACKGROUND

• Ansari R M, et al., Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis. Diabetology, 2022. 3(3): p. 407-422.

  BACKGROUND

• 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.

  PMID: 32164638 BACKGROUND

• FDREMoH, 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.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Akine E Abosetugn, MPH

  Debre Berhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All clusters of study participants will be geographically isolated, and ensuring that intervention and control groups are not exposed to each other. Study participants, HEW and HDA, will be blinded to the outcome interest of the study to avoid the hawthorn effect.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)