UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010529 |
|---|---|
| Receipt number | R000012312 |
| Scientific Title | A randomized controlled trial for the effectiveness of the postcard intervention against depression among community-dwelling older adults |
| Date of disclosure of the study information | 2013/04/18 |
| Last modified on | 2014/10/18 11:14:35 |
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Basic information
Public title
A randomized controlled trial for the effectiveness of the postcard intervention against depression among community-dwelling older adults
Acronym
The postcard intervention against depression among community-dwelling older adults: a randomized controlled trial
Scientific Title
A randomized controlled trial for the effectiveness of the postcard intervention against depression among community-dwelling older adults
Scientific Title:Acronym
The postcard intervention against depression among community-dwelling older adults: a randomized controlled trial
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Depression in older adults deteriorates quality of life and increases morbidity, mortality and medical expenses. Medicine and social policy should work together to decrease this burden. Existing prevention studies are often based on time-consuming psychotherapies, which therefore are not feasible for a wide application at the community level. Postcard interventions have been shown to be effective for patients after hospitalization for major depression, drug overdose, or self-harm.
The objective of the study is to examine the efficacy of a postcard intervention for depression among community-dwelling individuals aged 65 years or older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in the 15-item Geriatric Depression Scale scores
Key secondary outcomes
self-rated QOL as evaluated by visual analogue scales, self-rated basic ADL, and self-rated advanced ADL, The subjective sense of effectiveness of the intervention, recollection of the number of intervention mailings received, and the number of mailed replies will be evaluated to measure acceptability of the postcard intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Letters written on A4 paper with some colorful illustrations will be sent in a sealed envelope once a month for eight months. The letter will be composed of two parts: the first part will be a handwritten reply to messages returned from the participants if there are replies or comments, which aims to increase social connectedness and to enhance their self-respect; the second part will be seasonal greetings or news of the month from Kyoto, Japan, where the study authors are located, printed by computer. Kyoto is one of the most famous cultural centers in Japan and hosts various historical events that we believe will be of interest to participants living far from Kyoto.
Although a self-addressed stamped reply card will be enclosed with the letter, replying is not mandatory; this will be indicated on the reply card.
Interventions/Control_2
Control (no intervention)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older, exhibiting symptoms of depression with a score of ≥ 4 on the self-rated 15-item Geriatric Depression Scale, and reporting that they eat meals alone in the questionnaire
Key exclusion criteria
Participants will be excluded if they cannot understand and sign the informed consent form. Those who currently reside in a hospital or institution will be excluded.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Matsubayashi |
Organization
The Center for Southeast Asian Studies, Kyoto University
Division name
Field Medicine
Zip code
Address
46 Yoshida Simoadachi-cho, Sakyo-ku, Kyoto, 606-8501, Japan
TEL
075-753-7368
kmatsu@cseas.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hissei Imai |
Organization
The Center for Southeast Asian Studies, Kyoto University
Division name
Field Medicine
Zip code
Address
46 Yoshida Simoadachi-cho, Sakyo-ku, Kyoto, 606-8501, Japan
TEL
075-753-7368
Homepage URL
ihits@hotmail.com
Sponsor or person
Institute
Field medicine, Graduate School of Medicine, Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Tosa town
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 18 | Day |
Last modified on
| 2014 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012312
