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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038916
Receipt No. R000044371
Scientific Title Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan
Date of disclosure of the study information 2019/12/17
Last modified on 2019/12/17

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Basic information
Public title Group-based education for advance directives and advance care planning
Acronym Group-based education for advance directives and advance care planning
Scientific Title Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan
Scientific Title:Acronym Group-based educational intervention for advance care planning in primary care: a quasi-experimental study in Japan
Region
Japan

Condition
Condition Non-cancer chronic diseases
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether a video-supported group-formatted advance care planning program for older primary care patients with stable medical conditions results in a better advance directive completion rate and a greater likelihood of familial discussions regarding advance care planning compared to an individual discussion with a physician
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Advance directive completion
Key secondary outcomes Familial discussion
Satisfaction with the discussion session
Perceptions and attitudes about advance care planning

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 An educational video and brochure on advance care planning and advance directives were offered to all participants in the study. Then, participants in the intervention arm attended a 60-minute group discussion with other participants, which was facilitated by one of the study investigators. The group discussion addressed preferences about medical care at the end of life and the purpose of advance care planning. After the discussion, the participants were tracked for a period of time during which two regular visits to their attending physician were made. Their physicians allocated time for answering questions about the advance care planning if it was needed.
Interventions/Control_2 After watching the video, participants in the control arm engaged in a 20-minute individual discussion with their primary care physician on the same discussion topics. After the discussion, the follow-up visits were done in the same manner as those for participants in the intervention arm.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Eligible participants were adult patients aged 65 years or older who regularly visited an assigned physician in the trial site for chronic illness care. They were required to have seen their physicians more than three times and to be legally competent.
Key exclusion criteria Those who had already completed advance directives or living wills were ineligible for this study. Those who regularly visited another physician of any specialty were also excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shuji
Middle name
Last name Tsuda
Organization Kikugawa Family Medicine Center
Division name Medical Department
Zip code 437-1507
Address 1055-1 Akatsuchi, Kikugawa, Shizuoka
TEL 0537-73-2267
Email syu-net@ba3.so-net.ne.jp

Public contact
Name of contact person
1st name Shuji
Middle name
Last name Tsuda
Organization Kikugawa Family Medicine Center
Division name Medical Department
Zip code 437-1507
Address 1055-1 Akatsuchi, Kikugawa, Shizuoka
TEL 0537-73-2267
Homepage URL
Email syu-net@ba3.so-net.ne.jp

Sponsor
Institute Kikugawa Family Medicine Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel 053-435-2680
Email rinri@hama-med.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 菊川市家庭医療センター

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 17 Day

Related information
URL releasing protocol https://www.hama-med.ac.jp/research/clinical-res/erc/index.html
Publication of results Unpublished

Result
URL related to results and publications https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201402225778227537&rel=1#%7B%22category%22%3A%220%22%2C%
Number of participants that the trial has enrolled 109
Results
Advance directive completion rates were high for both group and individual arms but did not significantly differ between arms (85.7% vs. 80.4%, p=0.45). Only one-fifth of patients in both arms discussed advance care planning with their family after the intervention (20.7% and 21.7%, p=0.89). Patients in the group arm rated their experience slightly higher than those in the individual arm (4.2 and 3.9 out of 5, p=0.023).
Results date posted
2019 Year 12 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants' mean age was 76.1 in the group arm and 78.8 in the individual arm. Most of them perceived their health status as good or excellent (88.8% and 73.9%, respectively). Only 11.5% and 13.0% of the participants in each arm were familiar with advance directives before the intervention.
Participant flow
A total of 133 eligible older adults were invited to participate. Of them, 109 agreed to participate, with 63 assigned to the group arm and 46 to the individual arm. After the allocation, three and two participants in the group and individual arms, respectively, did not attend the discussion session, and three and nine, respectively, did not complete the second questionnaire after engaging in their allocated discussion session.
Adverse events
None
Outcome measures
Advance directive completion
Familial discussions
Satisfaction with the discussion sessions
Perceptions and attitudes about advance care planning
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 01 Day
Date of IRB
2013 Year 03 Month 29 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2014 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 17 Day
Last modified on
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044371

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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