UMIN-CTR Clinical Trial

Public title

10-year October/April Follow-up Evaluation of Multidisciplinary Community Outreach Services study

Acronym

OCTAP-10 study

Scientific Title

10-year Follow-up Evaluation of Multidisciplinary Community Outreach Services study

Scientific Title:Acronym

OCTAP-10 study

Region

Japan

Condition

Mental illness

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to undertake a 10-year longitudinal survey involving newly enrolled service users and their families who are recipients of case management services provided by a multidisciplinary outreach team. The overarching goal of this study is to comprehensively examine the trajectories of participants' lives through the investigation of subjective, social, and clinical outcomes as well as process outcomes related to service delivery.

Basic objectives2

Others

Basic objectives -Others

This study is an observational research project aimed at annually assessing the natural course of new service users and their families under a multidisciplinary outreach team for a period of ten years. More specifically, this study aims to examine the associations between changes in service users' subjective outcomes and changes in social, clinical, and service process-related outcomes. Additionally, it seeks to investigate the associations between the subjective outcomes of service users and those of their families.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Quality of Life (Recovering Quality of Life - 10 items: ReQoL-10)

Key secondary outcomes

Patient-reported outcome measures (assessed annually)
- Personal agency Five-item Subjective and Personal Agency scale: SPA-5)
- Loneliness (the 10-item UCLA Loneliness Scale: UCLA-LS-10)
- Mental health (Patient Health Questionnaire-2: PHQ-2)
- Well-being (A single-item scale)

Staff-rated outcome measures (assessed annually)
- Hospitalization
- Physical health (Charlson Comorbidity Index: CCI)
- Medication prescription and adherence
- Service utilization within the team
- Service utilization outside the team
- Symptoms (Clinical Global Impression: CGI)
- Functioning (12-item World Health Organization Disability Assessment Schedule: WHO-DAS-12)

Family-reported outcome measures (assessed annually)
- Quality of life (Recovering Quality of Life - 10 items: ReQoL-10)
- Well-being (A single-item scale)
- Caregiver burden (8-item Zarit Burden Index: ZBI-8)
- Family Relationships (Family Questionnaire: FQ)
- Questions on Living and Economic Conditions (Original 2 items)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

55

years-old

>

Gender

Male and Female

Key inclusion criteria

New service users who meet the following four criteria:

1) Receiving support from a multidisciplinary outreach team consisting of three or more professions.
2) Commencing the utilization of services from each team between October 1, 2023, and September 30, 2025.
3) Diagnosis of a mental disorder based on the ICD-10 criteria.
4) Age under 55 years old.


Family members who meet the following two criteria:
1) Family members who reside with the participating service users in the survey, live in close proximity to the service users, or frequently visit the service users' residence.
2) key caregivers within the family members.

Key exclusion criteria

Service Users:

1) Service users who, at the start of service utilization, cannot be provided with research explanatory materials.
2) Service users who register with a multidisciplinary outreach team for temporary purposes.
3) Service users for whom tracking is anticipated to be difficult due to personal reasons (e.g., moving in the near future).


Family Members:
Individuals who have decision-making problems such as dementia that raise doubts about their capacity to provide informed consent.

Target sample size

920

Name of lead principal investigator

1st name	Sosei
Middle name
Last name	Yamaguchi

Organization

National Center of Neurology and Psychiatry

Division name

National Institute of Mental Health, Department of Community Mental Health & Law

Zip code

187-8553

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

TEL

042-346-2039

Email

sosei.yama@ncnp.go.jp

Name of contact person

1st name	Kaori
Middle name
Last name	Usui

Organization

National Center of Neurology and Psychiatry

Division name

National Institute of Mental Health, Department of Community Mental Health & Law

Zip code

187-8553

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

TEL

042-346-2039

Homepage URL

Email

usuikaori@ncnp.go.jp

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Center of Neurology and Psychiatry, Ethics Committee

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

Tel

042-341-2712(7828)

Email

rinri-jimu@ncnp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

09

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

07

Month

19

Day

Date of IRB

2023

Year

08

Month

23

Day

Anticipated trial start date

2023

Year

10

Month

01

Day

Last follow-up date

2036

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This research constitutes a multisite study involving 23 community agencies (multidisciplinary outreach teams). The recruitment period for this study is slated to extend over two years, commencing from October 1, 2023, and concluding on September 30, 2025. The maximum enrollment limit for each agencies has been set at 20 new service users and their 20 family members. Consequently, the theoretical upper limit for the total number of participants stands at 920 (23 * [20+20]). However, it is envisaged that certain participating institutions will not have a cohort of more than 10 new service users within the two-year timeframe. Additionally, it is also postulated that a portion of the new service users may live alone without family members. Hence, the actual participant number is expected to be substantially lower than the theoretical maximum of 920.

Registered date

2023

Year

09

Month

22

Day

Last modified on

2024

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059629