UMIN-ICDS Clinical Trial

Public title

A Survey of Post-Discharge Home Life in Stroke Patients and Their Caregivers

Acronym

A Survey of Post-Discharge Home Life in Stroke Patients and Their Caregivers

Scientific Title

A Survey on the Performance of Meaningful Activities, Perceived Caregiving Burden, and Support Needs Among Stroke Patients and Their Caregivers Following Return Home

Scientific Title:Acronym

A Survey on the Performance of Meaningful Activities, Perceived Caregiving Burden, and Support Needs Among Stroke Patients and Their Caregivers Following Return Home

Region

Japan

Condition

stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is a longitudinal investigation of stroke patients who have returned home from a post-acute rehabilitation ward and their primary caregivers, examining the relationship between the performance of and satisfaction with meaningful activities after discharge and health-related quality of life (HRQOL), perceived caregiving burden, and support needs.

Basic objectives2

Others

Basic objectives -Others

The study aims to examine the impact of participants engagement in meaningful activities on improvements in health-related quality of life and reductions in caregiver burden, while also identifying unmet needs and gaps in support following discharge. Ultimately, the study seeks to contribute to improving the quality of discharge support provided in acute rehabilitation wards and community-based rehabilitation services.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Levels of Performance and Satisfaction Scores for Meaningful Activities After Discharge

Key secondary outcomes

Health-related Quality of Life (EQ-5D-5L)
Caregiver Burden (J-ZBI_8)
PHQ-2 Japanese Version (Symptom Assessment Version)
Analysis of Unmet Needs

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible participants include patients discharged from our hospitals post-acute rehabilitation ward to their homes following a stroke, as well as their primary caregivers.

Key exclusion criteria

1) If a research subject (participant) declines to participate in the study or withdraws their consent;
2) If, after enrollment, it is determined that the subject no longer meets the eligibility criteria;
3) If the principal investigator or a co-investigator determines that it is necessary to terminate the study for any other reason;

Target sample size

150

Name of lead principal investigator

1st name	yusuke
Middle name
Last name	niijima

Organization

Aizawa Hospital

Division name

Rehabilitation Ward

Zip code

390-8510

Address

2-5-1 Honjo, Matsumoto-shi, Nagano, Japan

TEL

0570-03-3600

Email

26ms125e@shinshu-u.ac.jp

Name of contact person

1st name	yusuke
Middle name
Last name	niijima

Organization

Aizawa Hospital

Division name

Rehabilitation Ward

Zip code

390-8510

Address

2-5-1 Honjo, Matsumoto-shi, Nagano, Japan

TEL

0570-03-3600

Homepage URL

Email

26ms125e@shinshu-u.ac.jp

Institute

Aizawa Hospital

Institute

Department

Personal name

Organization

Shinshu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Shinshu University

Name of secondary funder(s)

Organization

Aizawa Hospital

Address

2-5-1 Honjo, Matsumoto-shi, Nagano, Japan

Tel

0570-03-3600

Email

kenkyu@ai-hosp.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

相澤病院 (Aizawa Hospital)

Date of disclosure of the study information

2026

Year

11

Month

11

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

Preinitiation

Date of protocol fixation

2026

Year

10

Month

18

Day

Date of IRB

2026

Year

10

Month

19

Day

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective studies without intervention and survey-based research

Registered date

2026

Year

11

Month

11

Day

Last modified on

2026

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072669