NCT06203730

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

December 14, 2023

Last Update Submit

April 16, 2024

Conditions

Keywords

double ABC-X model; MHD; quality of life; dyadic psychological intervention strategy

Outcome Measures

Primary Outcomes (3)

  • 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"

  • 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"

  • 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 Outcomes (4)

  • anxiety of caregivers burden

    "Baseline" and "Immediately after the intervention"

  • depression of caregivers

    "Baseline" and "Immediately after the intervention"

  • caregivers'burden

    "Baseline" and "Immediately after the intervention"

  • Caregiving competence of caregivers

    "Baseline" and "Immediately after the intervention"

Study Arms (2)

Routine care

NO INTERVENTION

The Blood purification Center provides routine care for MHD patients

dyadic psychological intervention strategy

EXPERIMENTAL

an intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management

Behavioral: dyadic psychological intervention strategy

Interventions

an intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management

dyadic psychological intervention strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou People's Hospital

Taizhou, Jiangsu, 0523, China

RECRUITING

Related Publications (1)

  • Zhang L, Chen Y, Tang W, Wang Q, Zou L, Zhou L. Effects of dyadic psychoeducational interventions for haemodialysis patients and their family caregivers: a randomised controlled trial. BMC Nurs. 2025 Mar 4;24(1):244. doi: 10.1186/s12912-025-02835-1.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief nurse

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 12, 2024

Study Start

January 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

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