Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis

Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis - SDT-MI for HD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059317

Enrollment

Registered

2025-10-08

Start date

2025-12-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease (outpatients receiving hemodialysis)

Interventions

As &quot

educational material-based knowledge provision,&quot

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 onlin

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1.Cognitive impairment 2.Severe comorbidities such as significant visual impairment, lower limb amputation, cerebrovascular disease, heart failure, or malignancy

Design outcomes

Primary

Measure	Time frame
nterdialytic weight gain (IDWG). The mean IDWG will be measured at baseline, immediately after the intervention, 3 months, and 6 months after completion, and changes over time will be evaluated.	—

Secondary

Measure	Time frame
1. Psychological variables based on the Self-Determination Theory constructs Assessed using the Japanese version of the Self-Determination Theory measurement scales (Yamamoto et al., 2009) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. Health Care Climate Questionnaire (HCCQ): one-factor, 6-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). Treatment Self-Regulation Questionnaire (TSRQ): three-factor, 15-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). Perceived Competence Scale (PCS): one-factor, 4-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). 2. Self-management behavior Assessed using the Hemodialysis Self-Management Instrument (HDSMI, Japanese version; Nozawa et al., 2007) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. 3. Health-related quality of life (HR-QOL) Assessed using the Japanese version of the SF-8 Health Survey (Fukuhara et al., 2005) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. The SF-8 consists of eight subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and yields Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.	—

Measure

Time frame

1. Psychological variables based on the Self-Determination Theory constructs Assessed using the Japanese version of the Self-Determination Theory measurement scales (Yamamoto et al., 2009) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. Health Care Climate Questionnaire (HCCQ): one-factor, 6-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). Treatment Self-Regulation Questionnaire (TSRQ): three-factor, 15-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). Perceived Competence Scale (PCS): one-factor, 4-item scale; 7-point Likert scale (1 = not at all true - 7 = very true). 2. Self-management behavior Assessed using the Hemodialysis Self-Management Instrument (HDSMI, Japanese version; Nozawa et al., 2007) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. 3. Health-related quality of life (HR-QOL) Assessed using the Japanese version of the SF-8 Health Survey (Fukuhara et al., 2005) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention. The SF-8 consists of eight subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and yields Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.

—

Countries

Japan

Contacts

Public ContactTamako Yonezawa

Kobe Women's University Doctoral Program, Graduate School of Nursing

k5820103@suma.kobe-wu.ac.jp078-303-4705

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026