Clinical Trial: Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A randomized controlled trial (Japan)

Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063584) titled 'Effectiveness of web-based intervention for life-change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: A randomized controlled trial' on Nov. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - family caregivers of community-dwelling individuals with acquired brain injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The object of this research is to examine the effectiveness of a web-based intervention known as the Koji-fam.net 3-day program (KF3 PGM) for life-change adaptation of family caregivers of community-dwelling individuals with ABI. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants in the intervention group will access a program consisting of ecomapping and a message board (an anonymous online communication system) via a dedicated website for 5-15 minutes per day over three consecutive days. Interventions/Control_2 - Participants in the waitlist control group will continue their usual daily activities and will be provided with information about the program after completing the final survey.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Providing care for a family member or relative. 2. Having a primary care recipient under their care who has been diagnosed with higher brain dysfunction. 3. Being able to respond in Japanese in an environment with access to the Internet. Key exclusion criteria - 1. Unable to provide informed consent to participate in the study. 2. Younger than 18 years of age. 3. Having missing data on the Life Change Adaptation Scale at baseline. 4. Failing the attention check in the baseline survey. 5. Deemed ineligible to participate in the study by the internet survey panel provider Target Size - 160

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 10 Day Anticipated trial start date - 2026 Year 12 Month 15 Day Last follow-up date - 2027 Year 01 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072761

Disclaimer: Curated by HT Syndication.