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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04082871
Other study ID # 1IRB/2016/04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date January 10, 2017

Study information

Verified date September 2019
Source Applied Science Private University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study sought to assess the impact of the MMR service on identifying and resolving TRPs, improving adherence, depression and anxiety scores in females diagnosed with depression and anxiety in Jordan


Description:

Participants were recruited into this single-blind parallel randomized controlled trial and randomized into active and control groups. A clinical pharmacist identified TRPs for all participants. Adherence, depression and anxiety scores were assessed. Active group patients received the MMR service: pharmacist-delivered counseling and a letter with recommended changes in the patient's treatment plan was sent to the patient's psychiatrist to be applied. Control group participants did not receive the intervention. Follow-up assessments were completed for all patients at 3 months from baseline. Main outcome measures were TRPs, adherence, depression and anxiety scores.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date January 10, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Jordanian females or residents in Jordan for the last 12 months and planning to stay in Jordan for 6 months (the study follow-up period),

- above the age of 18 years

- diagnosed with depression and/or anxiety for at least 4 weeks duration

- taking medications for depression and/or anxiety

Exclusion Criteria:

- presence of a cognitive problem or sensory impairment which may prevent communication with the patient (reported by the patient's psychiatrist)

- being not able to speak or write Arabic (reported by the patient)

Study Design


Intervention

Other:
Medication management review
The researcher screened each completed an MMR template and verified that all information in each patient template was complete. A classification system was then used to identify the TRPs which either actually or potentially interfered with the clinical outcomes for each patient.[19] This system was explained in detail and applied successfully in many previous studies.[10, 14, 20] The researcher then identified TRPs for each patient in both groups using evidence-based medicine. The TRPs including unneeded drug treatment, untreated condition/s, efficacy/effectiveness issues, safety issues, inadequate knowledge, inappropriate adherence to pharmacological therapy, inappropriate adherence to self-care activities and miscellaneous problems.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Applied Science Private University

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety the medication management review service will be measured by the reduction of treatment related number after providing the service 6 months
Secondary Patient's satisfaction with the medication management review service satisfaction will be measured by the willingness of patients to pay for the provided services 6 months
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