跳至主要内容
临床试验/NCT04082871
NCT04082871已完成不适用

Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety

Applied Science Private University0 个研究点目标入组 73 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
主要终点
Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This single-blind parallel randomized controlled trial

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Medication management review (Other)

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

干预措施: Medication management review (Other)

结局指标

主要结局

Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety

时间窗: 6 months

the medication management review service will be measured by the reduction of treatment related number after providing the service

次要结局

  • Patient's satisfaction with the medication management review service(6 months)

研究者

申办方类型
Other
责任方
Sponsor

相似试验