ChiCTR2000040292Not yet recruitingUnknown
Effectiveness of a nurse-led community-based self-management program for patients with type 2 diabetes mellitus in Western Ethiopia: A pilot study
From the university's budget1 site in 1 country76 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
- To determine the rate of eligibility, recruitment, retention, and percentage of missing data at the item level of the questionnaire in a nurse-led community-based DSMES intervention among adult patients with type 2 diabetes and their family caregivers;
- To estimate the effect sizes of HbA1c, lipid profiles, SBP, DBP, BMI, self-care behaviors, quality of life, and family support behavior for the future full-scale study among adult patients with type 2 diabetes mellitus;
- To examine the preliminary effect of a nurse-led community-based DSMES on HbA1c, lipid profiles, SBP, DBP, BMI, self-management behaviors, quality of life, and level of family support among adult patients with type 2 diabetes mellitus;
- To examine the preliminary effect of a nurse-led community-based DSMES on family support behavior among family caregivers of adult patients with type 2 diabetes;
- To explore the acceptability of DSMES intervention among adult patients with type 2 diabetes mellitus and their family caregivers.
Study Design
- Study Type
- Interventional
- Primary Purpose
- 随机抽样
- Masking
- None
Eligibility Criteria
- Ages
- 18 to No (—)
- Sex
- All
Inclusion Criteria
- •Patients will be included if: -
- •diagnosed with type 2 diabetes mellitus (the diagnosis will be retrieved from the patient's medical records);
- •aged 18 years or above;
- •came from two selected Kebeles of the city;
- •taking medication treatments (insulin and/or oral hypoglycemic agents);
- •sign a written informed consent to participate in the study.
- •The family member will be included if: -
- •one primary family caregiver;
- •aged 18 years or above;
- •has the willingness to provide support; and
- •living in the same home with the patient.
Exclusion Criteria
- •The patients will be excluded if: -
- •patients with cognitive impairment. The cognitive status of the patients will be retrieved from the medical record of the patient;
- •unable to nominate one family member who can support them in DM management,
- •a pregnant woman with type 2 diabetes. She will be excluded due to possible difficulty in completing the intervention and follow-up related to pregnancy-related physiologic changes,
- •patients with physical impairment like blindness, paralysis, etc. The patients may not be able to attend the DSMES sessions due to these impairments, and
- •unable to speak and understand the Afaan Oromoo language (the local popular spoken language). Since the intervention will be given in the Afaan Oromoo language, the patients unable to speak and understand the language may face the difficulty of continuing the education sessions.
- •The family member will be excluded if:
- •has physical limitations to perform caregiver responsibilities.
Arms & Interventions
Two groups
Diabetes self-management education and support
Outcomes
Primary Outcomes
HbA1c
Time Frame: T0 and T2
Family member's family behavior
Time Frame: T0, T1 and T2
Secondary Outcomes
- Lipid profiles(T0, T1 and T2)
- Blood pressure(T0, T1 and T2)
- Self-management practices(T0, T1 and T2)
- Quality of life(T0 and T2)
- Patient-reported family support(T0, T1 and T2)
- Acceptability of the intervention(T2)
Investigators
Study Sites (1)
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