NCT06112925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 5, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Treatment outcomesMedication adherenceDiabetes Mellitus and HypertensionSouthwest Ethiopia

Outcome Measures

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.

    It was a 6 months study period

Study Arms (2)

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.

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.

Interventions

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.

Medication Therapy Management

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mattu Univesity

Addis Ababa, Mettu, 318, Ethiopia

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionMedication Adherence

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The study participants and attending healthcare providers were blinded of participants' treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There were two groups of study population.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 5, 2023

First Posted

November 2, 2023

Study Start

March 27, 2022

Primary Completion

June 16, 2022

Study Completion

December 1, 2022

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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

Locations