Depression, AnxietyNCT04082871
Medication Review in Women With Depression and Anxiety
A study testing Medication management review in people with Depression, Anxiety and Adherence, Patient, run by Applied Science Private University.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Depression, Anxiety, Adherence, Patient
- What is being tested?
- Medication management review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 10 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety
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
Read the 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.
- Conditions
- Depression, Anxiety, Adherence, Patient
- Being tested
- Medication management review
- Keywords
- Medication management review service, Pharmaceutical care, Clinical pharmacist
- Medical subject headings
- Depression, Anxiety Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication management reviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Other: Medication management review |
| Control | Active comparator | 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 Receives: Other: Medication management review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Patient's satisfaction with the medication management review service
satisfaction will be measured by the willingness of patients to pay for the provided services
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Aug 2016
- Primary completion1 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082871
- Sponsor's protocol ID
- 1IRB/2016/04
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT04082871
- Acronym / sponsor ID
- 1IRB/2016/04
- Conditions
- Depression, Anxiety, Adherence, Patient
- Keywords
- Medication management review service, Pharmaceutical care, Clinical pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Medication management reviewAll 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 | Active comparator | Other: Medication management reviewControl 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication management reviewThe 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. | Other | Control, Intervention |
Primary outcome
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
1 secondary outcome
Patient's satisfaction with the medication management review service
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Medication management review in people with Depression, Anxiety and Adherence, Patient, run by Applied Science Private University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.