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Recruitment status Completed
Unique ID issued by UMIN UMIN000010529
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 &#8805; 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
Email 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
Email ihits@hotmail.com

Sponsor
Institute Field medicine, Graduate School of Medicine, Kyoto university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012312


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