UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041671 |
|---|---|
| Receipt number | R000047563 |
| Scientific Title | Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2024/09/08 14:41:28 |
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Basic information
Public title
Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Acronym
Evaluation of community pharmacist-provided telephone interventions to SSRI/SNRI-treated patients
Scientific Title
Evaluation of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Scientific Title:Acronym
Evaluation of community pharmacist-provided telephone interventions to SSRI/SNRI-treated patients
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effect of community pharmacist-provided telephone interventions to improve adherence of SSRI/SNRI-treated patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment persistence rate
Key secondary outcomes
DAI-10, medication adherence, Pharmacy satisfaction, Utilization of CBT-A
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
3-month treatment persistence rate for the group of usual medication guidance plus telephone support (intervention group)
1.Telephone support is provided 3 times in the middle of the day before the next scheduled visit to the clinic.
2. If any side effects are found, Pharmacist will respond to them according to the protocol.
3.Support for anxiety about medication is provided through the cognitive-behavioral therapy approach (CBT-A).
Interventions/Control_2
Treatment persistence rate at 3 months in the usual medication guidance group (control group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients being prescribed an SNRI/SSRI for the first time
2.Patients who visit a clinic where the research co-investigator works and bring a prescription issued by the clinic to the research co-investigator's pharmacy
Key exclusion criteria
1.Patients in the hospital
2.Patients who were previously prescribed SNRI/SSRI
3.Men and women under the age of 20
4.Patients who did not get their consent to participate in the study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Fumiyuki |
| Middle name | |
| Last name | Watanabe |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Pharmacy practice in primary care
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi, Chiba, Japan
TEL
047-465-7394
watanabe.fumiyuki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiyuki |
| Middle name | |
| Last name | Watanabe |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Pharmacy practice in primary care
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi, Chiba, Japan
TEL
047-465-7394
Homepage URL
watanabe.fumiyuki@nihon-u.ac.jp
Sponsor or person
Institute
School of Pharmacy, Nihon University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, School of Pharmacy, Nihon University
Address
7-7-1 Narashinodai, Funabashi, Chiba, Japan
Tel
047-465-5919
pha.res-staff@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Poster presentation at the 42nd Annual Conference of the Japanese Society for Social Psychiatry
Publication of results
Published
Result
URL related to results and publications
Poster presentation at the 42nd Annual Conference of the Japanese Society for Social Psychiatry
Number of participants that the trial has enrolled
116
Results
After one month of treatment, the treatment continuation rate was 71.4% in the intervention group and 66.7% in the control group. After 3 months of treatment, the treatment continuation rate was 55.4% in the intervention group and 56.7% in the control group. Comparison of treatment retention rates between groups showed no significant differences.
Results date posted
| 2024 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intervention group consisted of 56 participants (males: 21, females: 35) and the control group consisted of 60 participants (males: 31, females: 29). The mean age was 35.2 years for the intervention group and 36.6 years for the control group.
Participant flow
After one month of treatment, 16 patients in the intervention group and 20 in the control group withdrew, and after three months of treatment, 9 patients in the intervention group and 6 in the control group withdrew.
Adverse events
None
Outcome measures
After one month of treatment, the treatment continuation rate was 71.4% in the intervention group and 66.7% in the control group. After 3 months of treatment, the treatment continuation rate was 55.4% in the intervention group and 56.7% in the control group. Comparison of treatment retention rates between groups showed no significant differences. The protocol was used by 10 of the 56 participants in the intervention group.The side effects complained of were nausea in 8 cases, somnolence in 1 case, and headache in 1 case. In nausea, following the protocol, 4 cases practiced response with coping medications, 3 cases practiced non-medication response, and 1 case practiced discontinue target medication and recommend medical consultation. In somnolence, non-medication response was practiced, and in headache, response with coping medications was practiced. No significant differences were found for DAI-10 either at the start or at the end of the study. Patient satisfaction was also not significantly different.14 participants (8 in the intervention group and 6 in the control group) responded to the withdrawal questionnaire. The most common reason given for withdrawal was that I feel better.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047563
