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

Sponsor

Mattu University (Other)

Overall Status

Completed

CT.gov ID

NCT06112925

Collaborator

(none)

386

Enrollment

Location

Arms

8.2

Actual Duration (Months)

47.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Hypertension	Other: Medication Therapy Management	N/A

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

Study Type:

Interventional

Actual Enrollment :

386 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There were two groups of study population.There were two groups of study population.

Masking:

Double (Participant, Care Provider)

Masking Description:

The study participants and attending healthcare providers were blinded of participants' treatment group.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 27, 2022

Actual Primary Completion Date :

Jun 16, 2022

Actual Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mattu Univesity	Addis Ababa	Mettu	Ethiopia	318

Sponsors and Collaborators

Mattu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tadesse Sheleme Achalu, Lecturer, Mattu University

ClinicalTrials.gov Identifier:

NCT06112925

Other Study ID Numbers:

MattuU

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tadesse Sheleme Achalu, Lecturer, Mattu University

Treatment outcomes

Medication adherence

Diabetes Mellitus and Hypertension

Southwest Ethiopia

Additional relevant MeSH terms:

Hypertension

Diabetes Mellitus

Study Results

No Results Posted as of Nov 2, 2023