Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058743) titled 'Research to Investigate the Feasibility and Effectiveness of a Support Program for Patients With Early-Stage Kidney Disease' on Aug. 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Iwate Prefectural University

Condition: Condition - diabetic nephropathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to explore the feasibility and effectiveness of an online support program that promotes disease awareness and self-care behaviors in patients with early-stage diabetic nephropathy. The main objectives are to explore (1) the feasibility of recruitment and consent, (2) program completion, (3) the acceptability of evaluation indicators, (4) program acceptability, and (5) the potential effects of the program on disease awareness, self-efficacy, and self-care abilities. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention group: Distribution of pamphlets + implementation of support program (three remote group sessions every two weeks) (approximately one month) Interventions/Control_2 - Control group: Distribution of pamphlets + usual care + implementation of a support program after the study period (a total of three remote group sessions) (approximately one month)

Eligibility: Age-lower limit - 30 years-old = Gender - Male and Female Key inclusion criteria - 1)Patients who have been informed by their attending physician that they have nephropathy(including those informed at the time of the request for participation in this study) 2)Individuals capable of making independent decisions regarding treatment 3)Individuals capable of independently accessing the remote program 4)Individuals in middle age(30-64 years old) 5)Individuals who have provided written content to participate in this study Key exclusion criteria - 1) Individuals who are unable to make independent decisions regarding treatment due to cognitive impairment or other reasons 2) Individuals who have difficulty accessing remote programs 3) Individuals who have not been informed by their attending physician about their kidney disease 4) Individuals currently receiving diabetes dialysis prevention guidance and management fees and undergoing medical care guidance 5) Individuals who have reached end-stage renal failure and have undergone artificial dialysis or kidney transplantation 6) Individuals currently receiving active treatment for conditions other than diabetes, such as malignant diseases Target Size - 24

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 06 Month 10 Day Date of IRB - 2025 Year 07 Month 28 Day Anticipated trial start date - 2025 Year 08 Month 08 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067166

Disclaimer: Curated by HT Syndication.