Diabetes MellitusNCT06112925
Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics
A study testing Medication Therapy Management in people with Diabetes Mellitus and Hypertension, run by Mattu University at 1 site in Ethiopia.
Trial summary
The goal of this interventional study was to assess the impact of medication therapy management on treatment outcomes and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Medication Therapy Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Mar 2022to 1 Dec 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age is greater than or equal to 18 years
- diagnosed with both diabetes mellitus and hypertension
Who cannot join
- unwillingness to participate
- mentally disabled
- lost to follow-up
- change follow up site
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics in Southwest Ethiopia: A Cluster Randomized Controlled Trial
The goal of this interventional study was to assess the impact of medication therapy management on treatment outcomes and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care.
Read the detailed description
This study aimed to assess the impact of medication therapy management intervention on treatment outcomes and medication adherence among patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. A cluster randomized controlled trial was conducted at outpatient clinics of public hospitals in Southwest Ethiopia from March to December, 2022. Hospitals were randomly assigned to either the interventional or the control group. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care and those attended hospital assigned to control group received the usual care only. A systematic random sampling technique was used to select the study participants from each hospital. The differences in proportion between the groups was determined using the Pearson chi-square. The independent sample t-test was be done to compare means between groups and paired t-test was used to compare means in between intervention and controlled group. The p-value of < 0.05 was used as a cut-off point to declare statistical significance.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Medication Therapy Management
- Keywords
- Treatment outcomes, Medication adherence, Diabetes Mellitus and Hypertension, Southwest Ethiopia
- Medical subject headings
- Diabetes Mellitus, Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Therapy ManagementOther
The medication therapy management intervention was delivered via the five (5) core components which include medication therapy review, personal medication record, medication-related action plan, intervention, and documentation and follow-up. The interventions was also given via educating patients about diabetes, hypertension, complications of diabetes and hypertension, impact of having diabetes and hypertension, antidiabetes and antihypertensive medications, goals of therapy for diabetes and hypertension, health promoting behaviours (healthy diet, regular exercise, salt reduction, \& smoking cessation), drug adherence, and self-monitoring of the diseases.
| Study group | Role | What they receive |
|---|---|---|
| Medication Therapy Management | Experimental | The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care. The medication therapy management services was provided by the clinical pharmacists. The study participants and attending healthcare providers were blinded of participants' treatment group. The intervention was done at initial visit and repeated at 3rd and 6th month of the initial visit. Receives: Other: Medication Therapy Management |
| No Medication Therapy Management | No intervention | The patients attending hospitals assigned to controlled group received usual care only. The usual care is patients' discussion with the attending physician, and nurse regarding their disease, medications, and subsequent appointments which may take approximately 5 minutes. Two consecutive follow-up visits were scheduled for 3rd month and 6th of initial visit for each patients in similar to interventional group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of of glycemic control, blood pressure control and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia
The proportion of patients who achieved good glycemic control changed from 15.5% to 43.3% from baseline to the end of the study in the intervention group. The current study also observed that the percentage of intervention group participants at the goal increased from 36.6% to 60.3% from baseline to 6-month.The adherence rate in the intervention group increased by 50% while remaining fairly constant in the control group.
Measured: It was a 6 months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start27 Mar 2022
- Primary completion16 Jun 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There were two groups of study population.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mattu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadesse Sheleme Achalu, Mattu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112925
- Sponsor's protocol ID
- MattuU
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Analysis done in group, not in individual. So, individual data will not be shared.
Publications
Sheleme T, Bekele F, Olika W, Sefera B. Impact of medication therapy management intervention on medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia: a cluster randomized controlled trial. Cardiovasc Diabetol Endocrinol Rep. 2025 Dec 16;11(1):41. doi: 10.1186/s40842-025-00254-4.
PubMed 41398916
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics in Southwest Ethiopia: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06112925
- Acronym / sponsor ID
- MattuU
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Treatment outcomes, Medication adherence, Diabetes Mellitus and Hypertension, Southwest Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Mattu UniversityUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Nov 2023 (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.
The goal of this interventional study was to assess the impact of medication therapy management on treatment outcomes and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care.
Detailed description
This study aimed to assess the impact of medication therapy management intervention on treatment outcomes and medication adherence among patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. A cluster randomized controlled trial was conducted at outpatient clinics of public hospitals in Southwest Ethiopia from March to December, 2022. Hospitals were randomly assigned to either the interventional or the control group. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care and those attended hospital assigned to control group received the usual care only. A systematic random sampling technique was used to select the study participants from each hospital. The differences in proportion between the groups was determined using the Pearson chi-square. The independent sample t-test was be done to compare means between groups and paired t-test was used to compare means in between intervention and controlled group. The p-value of < 0.05 was used as a cut-off point to declare statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There were two groups of study population.
| Arm | Type | Receives |
|---|---|---|
| Medication Therapy Management | Experimental | Other: Medication Therapy ManagementThe patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care. The medication therapy management services was provided by the clinical pharmacists. The study participants and attending healthcare providers were blinded of participants' treatment group. The intervention was done at initial visit and repeated at 3rd and 6th month of the initial visit. |
| No Medication Therapy Management | No intervention | –The patients attending hospitals assigned to controlled group received usual care only. The usual care is patients' discussion with the attending physician, and nurse regarding their disease, medications, and subsequent appointments which may take approximately 5 minutes. Two consecutive follow-up visits were scheduled for 3rd month and 6th of initial visit for each patients in similar to interventional group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age is greater than or equal to 18 years
- diagnosed with both diabetes mellitus and hypertension
Key exclusion criteria (5 listed)
- unwillingness to participate
- mentally disabled
- lost to follow-up
- change follow up site
- pregnant women
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 |
|---|---|---|
| Medication Therapy ManagementThe medication therapy management intervention was delivered via the five (5) core components which include medication therapy review, personal medication record, medication-related action plan, intervention, and documentation and follow-up. The interventions was also given via educating patients about diabetes, hypertension, complications of diabetes and hypertension, impact of having diabetes and hypertension, antidiabetes and antihypertensive medications, goals of therapy for diabetes and hypertension, health promoting behaviours (healthy diet, regular exercise, salt reduction, \& smoking cessation), drug adherence, and self-monitoring of the diseases. | Other | Medication Therapy Management |
Primary outcome
Change in percentage of of glycemic control, blood pressure control and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia
Time frame: It was a 6 months study period
The proportion of patients who achieved good glycemic control changed from 15.5% to 43.3% from baseline to the end of the study in the intervention group. The current study also observed that the percentage of intervention group participants at the goal increased from 36.6% to 60.3% from baseline to 6-month.The adherence rate in the intervention group increased by 50% while remaining fairly constant in the control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 41398916Sheleme T, Bekele F, Olika W, Sefera B. Impact of medication therapy management intervention on medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia: a cluster randomized controlled trial. Cardiovasc Diabetol Endocrinol Rep. 2025 Dec 16;11(1):41. doi: 10.1186/s40842-025-00254-4.
- Individual participant dataSharing planned: No. Analysis done in group, not in individual. So, individual data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Therapy Management in people with Diabetes Mellitus and Hypertension, run by Mattu 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in percentage of of glycemic control, blood pressure control and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia (time frame: It was a 6 months study period). 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 NCT06112925, which also lists 1 linked publication.
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 2 Nov 2023.