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CompletedNCT06112925Updated Nov 2, 2023

Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics

An interventional study of Medication Therapy Management in Diabetes Mellitus and Hypertension, sponsored by Mattu University. Completed at 1 site in Ethiopia. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Mattu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
386
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes Mellitus
  • Hypertension

Keywords

  • Treatment outcomes
  • Medication adherence
  • Diabetes Mellitus and Hypertension
  • Southwest Ethiopia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 386 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Mattu University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age is greater than or equal to 18 years
  • diagnosed with both diabetes mellitus and hypertension

Exclusion criteria

Exclusion Criteria:

  • unwillingness to participate
  • mentally disabled
  • lost to follow-up
  • change follow up site
  • pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
386 participants (actual)

Study arms

  • Experimental
    Medication Therapy Management

    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.

    Other: Medication Therapy Management

  • No intervention
    No Medication Therapy Management

    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.

Interventions

  • OtherMedication Therapy Management

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: It was a 6 months study period

07

Study locations

1 site
  • Mattu Univesity
    Addis Ababa, Mettu 318, Ethiopia
08

References and documents

Individual participant data

Plan to share: No — Analysis done in group, not in individual. So, individual data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06112925
Lead sponsor
Mattu University
Responsible party
Tadesse Sheleme Achalu (Lecturer, Mattu University) — Principal investigator
First posted
Nov 2, 2023
Start date
Mar 27, 2022
Primary completion
Jun 16, 2022
Completion
Dec 1, 2022
Last update
Nov 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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