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

October 30, 2023 updated by: Tadesse Sheleme Achalu, Mattu University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
386

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Mettu
      • Addis Ababa, Mettu, Ethiopia, 318
        • Mattu Univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
It was a 6 months study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mattu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MattuU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Analysis done in group, not in individual. So, individual data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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