Study on the Influence of Dyadic Psychoeducational Intervention on Patients With Maintenance Hemodialysis

End Stage Renal Disease on Dialysis Clinical Trial

— MHD  

Official title:

Application of Dyadic Psychological Intervention Strategy Based on Double ABC-X Model in Patients With Maintenance Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203730
• Other study ID #: LYZhang
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Jiangsu Taizhou People's Hospital
• Contact: Liyuan Zhang, Master
• Phone: 86 + 17851358412
• Email: zhangliyuan20230419[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims explored the effectiveness of dual psychological intervention strategies in improving the quality of life of MHD patients based on the theoretical guidance of double ABC-X model. To provide a scientific and effective dual psychological intervention strategy for MHD patients and their caregivers, in order to improve the quality of life of MHD patients, and to provide a reference for nurses in clinical blood purification centers to implement psychological intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria of MHD patients were: (1) meeting the diagnostic criteria of CKD; (2) Maintenance hemodialysis at the blood purification center of our hospital for more than 3 months; (3) over 18 years of age; (4) Volunteer to participate in this study.

• MHD caregiver inclusion criteria: (1) over 18 years of age; (2) Responsible for the main care tasks of MHD patients; (3) Volunteer to participate in this study.

Exclusion Criteria:

• Exclusion criteria for MHD patients: (1) Patients with cognitive impairment or audio-visual impairment unable to communicate normally; (2) Patients diagnosed with mental illness or who are receiving medication or psychotherapy for depression.

• MHD caregiver exclusion criteria: (1) Caregivers with cognitive impairment or audiovisual impairment unable to communicate normally; (2) Caregivers suffering from serious heart, brain, liver, kidney and other important organ diseases; (3) carers or paid carers.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Behavioral:
• dyadic psychological intervention strategy
an intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management

Locations

Country	Name	City	State
China	Taizhou People's Hospital	Taizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Taizhou People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life of patients with MHD	The Kidney Disease Quality of Life 36-item Short Form (KDQOL-36™) was used to measure quality of life in patients with MHD	"Baseline" and "Immediately after the intervention"
Primary	anxiety of patients with MHD	The hospital anxiety and depression scale (HADS) was used to measure anxiety in patients with MHD	"Baseline" and "Immediately after the intervention"
Primary	depression of patients with MHD	The hospital anxiety and depression scale (HADS) was used to measure depression in patients with MHD	"Baseline" and "Immediately after the intervention"
Secondary	anxiety of caregivers burden	The hospital anxiety and depression scale (HADS) was used to measure anxiety in caregivers	"Baseline" and "Immediately after the intervention"
Secondary	depression of caregivers	The hospital anxiety and depression scale (HADS) was used to measure depression in caregivers	"Baseline" and "Immediately after the intervention"
Secondary	caregivers'burden	The Zarit Caregiver Burden Interview (ZBI) was used to measure caregivers' burden	"Baseline" and "Immediately after the intervention"
Secondary	Caregiving competence of caregivers	The Caregiving Competence Scale (CCS) was used to measure caregiving competence of caregivers	"Baseline" and "Immediately after the intervention"