Effects of the integrative cognitive and self-management training program on cognitive functions, selfmanagement behaviors, and health-related quality of life among patients with end-stage renal disease undergoing hemodialysis: A blocked randomized controlled trial.

Effects of the integrative cognitive and self-management training program on cognitive functions, self-management behaviors, and health-related quality of life among patients with end-stage renal disease undergoing hemodialysis: A blocked randomized controlled trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250226004

Enrollment

Registered

2025-02-26

Start date

2025-02-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients with end-stage renal disease undergoing hemodialysis have problems with cognitive functions, self-management behaviors, and health-related quality of life. cognitive and self-management training program cognitive functions self-management behaviors health-related quality of life end-stage renal disease ESKD hemodialysis

Interventions

The intervention is designed to help individuals with ESKD undergoing hemodialysis improve their cognitive function, self-management behaviors, health-related quality of life, and kidney function as a

s scheduled dialysis day, ensuring accessibility and integration into routine care. This structured approach aims to enhance self-management skills and cognitive function, ultimately improving the qua

Experimental Behavioral,No Intervention Behavioral

The integrative cognitive and self-management training program.,Usual care.

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age ranges from 40 to 65 years old. 2. Initially undergoing HD for 1-3 months with stable vascular access. 3. No depression based on the patient health questionnaire (PHQ-9) screening and had scores exceeding 9 out of 27 (Lotrakul et al., 2008). 4. No cognitive impairment based on the Mini-Mental State Examination Thai (MMSE-Thai, 2002). The cutoff points for MMSE-Thai 2002 will be scores of 17 to 30 or 22 to 30 based on patient education levels of primary school and higher, varying based on the individual's level of education (The Committee prepared the Preliminary Brain Test, Thai version, 1999). 5. Not being bedridden or functionally dependent as indicated by having scores of 12 or higher (scores ranging from 0-20) using the Modified Barthel Activities of Daily Living Index (BAI) (Jitapunkul et al., 1994). 6. Be able to write, read, and communicate Thai language well.

Exclusion criteria

Exclusion criteria: 1. Having living alone. 2. Having paid caregivers. 3. Serious co-morbidity such as stroke or a heart attack. Discontinuation criteria: Participants will be discontinued from the study based on the following criteria: 1. Having severe illness or a critical phase requiring hospitalization during program participation. 2. Unable to participate in the intervention for all sessions.

Design outcomes

Primary

Measure	Time frame
cognitive functions, self-management behaviors, and health-related quality of life. Pre-experimental , week 8, and week 12 questionnaire	—

Secondary

Measure	Time frame
kidney function as assessed through blood tests. Pre-experimental , week 8, and week 12 Laboratory test	—

Countries

Thailand

Contacts

Public ContactBusayarat Loysak

Faculty of Nursing Burapha University

busayarat@pnc.ac.th0872404577

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026