Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059317) titled 'Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis' on Oct. 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kobe Women's University

Condition: Condition - End-stage renal disease (outpatients receiving hemodialysis) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to develop a remote support program to implement online motivational interviewing based on the framework of the Self-Determination Theory Healthcare Model for outpatients receiving hemodialysis at dialysis facilities, and to conduct an interventional study to evaluate its effects on optimizing interdialytic weight gain, improving self-management behaviors, and enhancing quality of life (QOL). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - As "educational material-based knowledge provision," participants will receive a pamphlet summarizing key points necessary for appropriate control of interdialytic weight gain, which will be distributed and explained in person. Subsequently, five online counseling sessions (approximately 30 minutes each) will be conducted based on the framework of the Self-Determination Theory healthcare model, using motivational interviewing (MI) techniques.

During each session, a goal-setting sheet that participants can complete themselves will be used as supplementary material and shared on screen to facilitate the following steps: (1) clarification of personal values, (2) collaborative setting of specific behavioral goals, (3) review of progress and adjustment of plans, and (4) resetting of goals. These processes aim to enhance intrinsic motivation and promote behavioral change. Interventions/Control_2 - Distribute a pamphlet on appropriate control of interdialytic weight gain and provide only educational material-based knowledge provision. No online interviews will be conducted.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Outpatients receiving maintenance hemodialysis (HD) three times per week at participating facilities 2. Patients who have been on dialysis for more than 6 months 3. Mean interdialytic weight gain over the past 4 weeks of >=4% after one non-dialysis day or >=6% after two non-dialysis days 4. Able to operate a smartphone Key exclusion criteria - 1.Cognitive impairment 2.Severe comorbidities such as significant visual impairment, lower limb amputation, cerebrovascular disease, heart failure, or malignancy Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 18 Day Anticipated trial start date - 2025 Year 12 Month 10 Day Last follow-up date - 2028 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067848

Disclaimer: Curated by HT Syndication.