End Stage Renal Disease on DialysisMHDNCT06203730
Study on the Influence of Dyadic Psychoeducational Intervention on Patients With Maintenance Hemodialysis
A study testing dyadic psychological intervention strategy in people with End Stage Renal Disease on Dialysis, run by Jiangsu Taizhou People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- dyadic psychological intervention strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lijuan Zhou contact
China1 site, 1 recruiting
- Recruiting
Taizhou People's Hospital
Taizhou, Jiangsu, 0523
Liyuan Zhang, Master, +8617851358412, zhangliyuan20230419@njmu.edu.cn
About this study
Official title: Application of Dyadic Psychological Intervention Strategy Based on Double ABC-X Model in Patients With Maintenance Hemodialysis
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.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- dyadic psychological intervention strategy
- Keywords
- double ABC-X model; MHD; quality of life; dyadic psychological intervention strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyadic psychological intervention strategyBehavioural
an intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: dyadic psychological intervention strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "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
Measured: "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
Measured: "Baseline" and "Immediately after the intervention"
Secondary outcomes (4)
anxiety of caregivers burden
The hospital anxiety and depression scale (HADS) was used to measure anxiety in caregivers
Measured: "Baseline" and "Immediately after the intervention"
depression of caregivers
The hospital anxiety and depression scale (HADS) was used to measure depression in caregivers
Measured: "Baseline" and "Immediately after the intervention"
caregivers'burden
The Zarit Caregiver Burden Interview (ZBI) was used to measure caregivers' burden
Measured: "Baseline" and "Immediately after the intervention"
Caregiving competence of caregivers
The Caregiving Competence Scale (CCS) was used to measure caregiving competence of caregivers
Measured: "Baseline" and "Immediately after the intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijuan Zhou, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203730
- Sponsor's protocol ID
- LYZhang
- Acronym
- MHD
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40038667
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Dyadic Psychological Intervention Strategy Based on Double ABC-X Model in Patients With Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT06203730
- Acronym / sponsor ID
- MHD / LYZhang
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- double ABC-X model; MHD; quality of life; dyadic psychological intervention strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | No intervention | –The Blood purification Center provides routine care for MHD patients |
| dyadic psychological intervention strategy | Experimental | Behavioral: dyadic psychological intervention strategyan intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dyadic psychological intervention strategyan intervention strategy for both patients and caregivers that combines psychotherapy techniques and health management | Behavioural | dyadic psychological intervention strategy |
Primary outcome
quality of life of patients with MHD
Time frame: "Baseline" and "Immediately after the intervention"
The Kidney Disease Quality of Life 36-item Short Form (KDQOL-36™) was used to measure quality of life in patients with MHD
anxiety of patients with MHD
Time frame: "Baseline" and "Immediately after the intervention"
The hospital anxiety and depression scale (HADS) was used to measure anxiety in patients with MHD
depression of patients with MHD
Time frame: "Baseline" and "Immediately after the intervention"
The hospital anxiety and depression scale (HADS) was used to measure depression in patients with MHD
4 secondary outcomes
anxiety of caregivers burden
Time frame: "Baseline" and "Immediately after the intervention"
depression of caregivers
Time frame: "Baseline" and "Immediately after the intervention"
caregivers'burden
Time frame: "Baseline" and "Immediately after the intervention"
Caregiving competence of caregivers
Time frame: "Baseline" and "Immediately after the intervention"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 40038667Zhang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijuan Zhou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dyadic psychological intervention strategy in people with End Stage Renal Disease on Dialysis, run by Jiangsu Taizhou People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Zhang, Master (86 + 17851358412, zhangliyuan20230419@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life of patients with MHD (time frame: "Baseline" and "Immediately after the intervention"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.