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Medication Review in Women With Depression and Anxiety

Primary Purpose

Depression, Anxiety, Adherence, Patient

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medication management review
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety focused on measuring Medication management review service, Pharmaceutical care, Clinical pharmacist

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Patient's satisfaction with the medication management review service
    satisfaction will be measured by the willingness of patients to pay for the provided services

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    September 6, 2019
    Sponsor
    Applied Science Private University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04082871
    Brief Title
    Medication Review in Women With Depression and Anxiety
    Official Title
    Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Applied Science Private University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Adherence, Patient
    Keywords
    Medication management review service, Pharmaceutical care, Clinical pharmacist

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Masking Description
    This single-blind parallel randomized controlled trial
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Medication management review
    Intervention Description
    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 Measure Information:
    Title
    Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety
    Description
    the medication management review service will be measured by the reduction of treatment related number after providing the service
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Patient's satisfaction with the medication management review service
    Description
    satisfaction will be measured by the willingness of patients to pay for the provided services
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Females diagnosed with depression and/or anxiety and attending the psychiatric clinics at Jordan University Hospital (JUH)
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Medication Review in Women With Depression and Anxiety

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