An interventional study of Intervention in Diabete Type 2, sponsored by Komfo Anokye Teaching Hospital. Completed at 1 site in Ghana. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Komfo Anokye Teaching Hospital · Not applicable, Interventional, and Supportive care
This is a randomized controlled trial assessing the effectiveness of a nurse led diabetes self management education(DSME) given over a 6 month period via mixed delivery strategy (in-person and via phone calls) on Hemoglobin A1c(HbA1c), fasting blood glucose(FBG), blood pressure, body weight and low density lipoprotein cholesterol(LDL-C).
The main question this research seeks to answer is
1. Does diabetes self-management education when combined with usual care improve glycaemic control when compared to usual care alone? Patients will be randomized into intervention and control groups. The intervention group will receive nurse led DSME using the American Association of diabetes educators 7 self care behaviour over a 6 month period. It will involve 3 monthly in-person sessions starting from the first day of recruitment as well as 2 weekly phone call sessions. This will be in addition to the usual care at the diabetes clinic.
The control group will receive usual diabetes care
This a randomized controlled parallel design among 74 Type 2 diabetes mellitus(T2DM) patients recruited from the Komfo Anokye Teaching Hospital Diabetes clinic.
The primary outcome is the mean change in HbA1c at 6 months
The secondary outcomes include:
STUDY PROTOCOL USUAL CARE The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills.
Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation.
Phone calls will be made to remind them of their clinic appointment for data collection.
THE INTERVENTION- DIABETES SELF-MANAGEMENT EDUCATION The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. An empowerment and interactive teaching model will be used with focus on behavioral assessment, goal-setting and problem-solving to promote autonomous self-regulation for better health and quality of life. A clinical sheet will be used while delivering the education to ensure that all core topics are covered.
For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model which focuses on: being active, healthy eating, monitoring blood glucose, healthy coping, reducing risks, problem solving and adherence to medication The participants are scheduled to attend a 1-hour individualized session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care . Subsequent consultations will be mainly feedback sessions, aimed at reviewing previously discussed matters, reinforcing key messages, addressing challenges and providing additional information.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 74 is close to the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Komfo Anokye Teaching Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The current standard practice (the usual care) includes an outpatient specialist service with patients scheduled every 1 to 6 months, depending on their diabetes control and complications profile. The other services provided include dietician appointments, laboratory investigations, clinical examinations, group education on self-management practices, and medication refills. Usual care by a doctor entails a 10-15 min standard doctors' consultation where the recent HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored diabetes education is offered. This enables the individual an opportunity to learn about self-management in a flexible and informal way. There is no structure to it and the information is offered according to what the patient requests to know as well as what the doctor thinks would be important for the patient to know, during that consultation. Phone calls will be made to remind them of their clinic appointment for data collection.
The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualized structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualized DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care
Behavioral: Intervention
The intervention group will receive the usual consultation from their doctor and referral to a diabetes educator for individualised structured DSME training. A clinical sheet will be used while delivering the education to ensure that all core topics are covered. For this study, 2 diabetes educators will offer the individualised DSME sessions using the American Association of Diabetes Education (AADE) 7 self-care behaviour model. The participants are scheduled to attend a 1-hour individualised session at the hospital every 3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the convenience of the participant to reinforce DSME for 6 months. The first session is arranged on the first day after consultation with the doctor. At the end of the sessions, the participants will receive a patient guide to diabetes booklet and graphic material illustrating several self-care activities such as foot care
Primary outcome measuring the mean change in HbA1c at 6 months
Mean change in HbA1c
Time frame: 6 months
Secondary outcome measuring the mean change in fasting blood glucose at 3 months
Mean change in fasting blood glucose 2) The mean change in blood pressure at 6 months 3) The mean change in body weight at 6 months 4) The mean change in LDL-C at 6 month
Time frame: 3 months
Secondary outcome measuring the mean change in blood pressure at 6 months
Mean change in blood pressure
Time frame: 6 months
Secondary outcome measuring the mean change in body weight at 6 months
Mean change in body weight
Time frame: 6 months
Secondary outcome measuring the mean change in low density lipoprotein cholesterol at 6 months
Mean change in low density lipoprotein cholesterol
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2024 to primary completion in Oct 2024, 8 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 8 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Komfo Anokye Teaching Hospital