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Medication Review in Women With Depression and Anxiety

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ClinicalTrials.gov Identifier: NCT04082871
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Applied Science Private University

Brief 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

Condition or disease Intervention/treatment Phase
Depression, Anxiety Adherence, Patient Other: Medication management review Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Following recruitment, participants were randomized into two groups (1:1 randomization), active and control, using the computer-generated randomization program (www.randomization.com). The researcher generated the allocation sequence, and assigned the participants to their group. Participant who came into the clinic during the clinic's working hours (Sunday to Thursday, from 9 am to 1 pm) were approached consecutively and allocated to the active or control group. Participants were not aware of which study group they were assigned to; only the researcher was aware of each patient's group assignment.

Participants in the active and control groups completed a baseline and follow-up (3 months from baseline) visits at the same outpatient psychiatric clinic with the researcher conducting the interview using the study tool to complete the MMR process.

Masking: Single (Participant)
Masking Description: This single-blind parallel randomized controlled trial
Primary Purpose: Treatment
Official Title: Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Intervention

All pharmacist level counseling and education regarding treatment, adherence and self-care activities were delivered to the active group patients only (planned to take 15 minutes). Patient level TRPs (any TRP that could be resolved via patient education and counseling) were resolved directly with the patient by the clinical pharmacist.

A letter with the identified TRPs (prioritized from most important to least important) for each patient in the active group was sent to the patient's psychiatrist by the researcher in sealed envelopes. The psychiatrist either accepted or rejected the recommendations. In case the recommendations were accepted, the psychiatrist implemented the recommended changes. Patients were informed by a phone call by the pharmacist to visit their psychiatrist soon after the recommendations were approved for the changes to be applied.

If the recommendations were rejected, the psychiatrist stated the reason of rejection and discussed it with the pharmacist.

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.

Active Comparator: Control

Control group patients also underwent the baseline interview with the researcher at the psychiatric clinic, TRPs were identified and documented. No intervention was provided by the pharmacist and no letter was sent to the patients' psychiatrists. In case a patient was found to have a life-threatening TRP, the patient was excluded from the study and reported to the psychiatrist due to ethical considerations.

After study completion, all patients in the control group received the MMR service, and a letter with their TRPs and recommendations to resolve them was sent by the pharmacist to their psychologist

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.




Primary Outcome Measures :
  1. Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety [ Time Frame: 6 months ]
    the medication management review service will be measured by the reduction of treatment related number after providing the service


Secondary Outcome Measures :
  1. Patient's satisfaction with the medication management review service [ Time Frame: 6 months ]
    satisfaction will be measured by the willingness of patients to pay for the provided services



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females diagnosed with depression and/or anxiety and attending the psychiatric clinics at Jordan University Hospital (JUH)
Accepts Healthy Volunteers:   No
Criteria

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)
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Responsible Party: Applied Science Private University
ClinicalTrials.gov Identifier: NCT04082871    
Other Study ID Numbers: 1IRB/2016/04
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Science Private University:
Medication management review service
Pharmaceutical care
Clinical pharmacist
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders