Peritoneal Dialysis (PD)NCT07677085
Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis
A study testing ITHBC-Based Comprehensive Nursing Intervention and Routine Care in people with Peritoneal Dialysis (PD) and Frailty Syndrome, run by Henan University at 1 site in China.
Trial summary
This study aims to evaluate the effects of a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC) on patients undergoing peritoneal dialysis with frailty syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis (PD), Frailty Syndrome
- What is being tested?
- ITHBC-Based Comprehensive Nursing Intervention and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Sep 2025
- 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
- age ≥ 18 years;
- a diagnosis of end-stage renal disease with an estimated glomerular filtration rate of < 15 mL/min/1.73 m² ;
- currently undergoing peritoneal dialysis with regular follow-up at the peritoneal dialysis clinic;
- a score of ≥ 3 on the Fried Frailty Phenotype Scale;
- provision of written informed consent and voluntary participation in this study.
Who cannot join
- presence of concurrent severe primary diseases, including malignant tumors;
- cognitive impairment or a diagnosed mental illness;
- limb dysfunction that precluded cooperation with the intervention.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan University School of Nursing and Health Sciences
Kaifeng, Henan, 475001
About this study
This study aims to evaluate the effects of a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC) on patients undergoing peritoneal dialysis with frailty syndrome.
The main questions it aims to answer include:
Read more
Can the ITHBC-based comprehensive nursing intervention improve patients' frailty status?
Can the intervention reduce patients' nutritional risk?
Can the intervention enhance patients' exercise self-efficacy, social support, and self-management behaviors?
Researchers will compare the ITHBC-based comprehensive nursing intervention (intervention group) with routine care (control group) to assess the effectiveness of the intervention program.
Participants:
The intervention group receives the ITHBC-based comprehensive nursing intervention (including personalized assessment, knowledge and belief reinforcement, skill development, goal setting and follow-up, and social support promotion) in addition to routine care for 3 months
The control group receives routine care (including admission education, standardized in-hospital health education, and monthly outpatient or telephone follow-up for 3 months)
Data are collected at baseline (T0), 1 month (T1), and 3 months (T2) post-intervention
Outcome measures include: frailty scores, nutritional risk scores, exercise self-efficacy scores, social support scores, and self-management behavior scores
- Conditions
- Peritoneal Dialysis (PD), Frailty Syndrome
- Being tested
- ITHBC-Based Comprehensive Nursing Intervention, Routine Care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITHBC-Based Comprehensive Nursing InterventionBehavioural
A 3-month comprehensive nursing program based on the Integrated Theory of Health Behavior Change (ITHBC), consisting of five phases: (1) personalized assessment of frailty, nutritional status, physical activity, social support, and self-management capabilities; (2) knowledge and belief reinforcement through video-based and handbook-based education; (3) skill and competency development in nutrition management, multicomponent exercise training, and medication guidance; (4) goal setting and follow-up with individualized diet and exercise plans, biweekly visits in the first month and monthly visits thereafter; and (5) social support promotion involving healthcare professionals, family members, and peer support groups.
Routine CareBehavioural
Routine nursing care for PD patients, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants in this arm received a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to routine care. The intervention consisted of five phases: personalized assessment, knowledge and belief reinforcement, skill and competency development, goal setting and follow-up, and social support promotion, delivered over a 3-month period. Receives: Behavioral: ITHBC-Based Comprehensive Nursing Intervention |
| Control Group | Active comparator | Participants in this arm received routine care, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fried Frailty Phenotype Scale
The Fried Frailty Phenotype Scale was developed by Fried et al. in 2001 and is recognized as the most widely used frailty assessment tool in the fields of gerontology and nephrology. This scale includes five components: unintentional weight loss, exhaustion, reduced grip strength, slow walking speed, and decreased physical activity. One point is assigned for each criterion that is met, yielding a total score that ranges from 0 to 5. A score of 0 indicates absence of frailty; scores of 1-2 suggest pre-frailty; and scores of 3 or more indicate frailty. The Cronbach's α coefficient for this scale was reported as 0.868.
Measured: Baseline, Month 1, Month 3
Chronic Kidney Disease Self-Management Scale
The Chronic Kidney Disease Self-Management Scale (CKD-SM), which was developed by Yu P. and colleagues, evaluates the self-management behavior level of patients undergoing home-based peritoneal dialysis. This scale contains 31 items, which cover four domains: dietary management (12 items), treatment management (9 items), physical activity management (5 items), and psychosocial management (5 items). Each item was scored on a 4-point Likert scale, with response options ranging from "never" to "always" and corresponding scores ranging from 1 to 4. The total score ranges from 31 to 124, with higher scores indicating stronger self-management abilities. The overall Cronbach's α coefficient of this scale was reported as 0.902, and the test-retest reliability was reported as 0.898.
Measured: Baseline, Month 1, Month 3
Secondary outcomes (4)
Nutritional Risk Screening Tool
The Nutritional Risk Screening Tool (NRS-2002), which was developed by Kondrup and colleagues, is an evidence-based screening tool for nutritional risk. The total score is calculated as the sum of three components: a disease severity score, a nutritional status impairment score, and an age score. Both the disease severity score and the nutritional status impairment score range from 0 to 3 points, with 1 additional point being added for patients aged ≥ 70 years. The total score ranges from 0 to 7 points, and a score of ≥ 3 indicates the presence of nutritional risk. The Cronbach's α coefficient for this scale was reported as 0.760, and the criterion validity was reported as 0.670.
Measured: Baseline, Month 1, Month 3
Self-Efficacy for Exercise Scale
The Self-Efficacy for Exercise Scale (SEE), which was developed by Resnick and colleagues and was adapted into a Chinese version by Lee and colleagues, assesses patients' confidence in their ability to adhere to an exercise regimen. This is a single-dimension scale consisting of nine items, each scored from 0 to 10, with response options ranging from "no confidence" to "very confident." The total score ranges from 0 to 90, with higher scores indicating greater patients' confidence in maintaining regular exercise. The Cronbach's α coefficient of this scale was reported as 0.75, and the content validity index was reported as 0.90
Measured: Baseline, Month 1, Month 3
Social Support Rating Scale
The Social Support Rating Scale (SSRS), which was developed by Xiao S., assesses an individual's level of social support. This scale includes three dimensions (objective support, subjective support, and utilization of social support), comprising a total of ten items. The total score ranges from 12 to 66, with higher scores indicating a higher level of social support. The Cronbach's α coefficient for the overall scale was reported as 0.896, and the dimension-specific Cronbach's α coefficients were reported to range from 0.833 to 0.896.
Measured: Baseline, Month 1, Month 3
Laboratory Parameters
Serum albumin, hemoglobin, and serum total protein levels were measured to evaluate nutritional status and anemia in patients.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis (PD)Studies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a quasi-experimental study using temporal (sequential) grouping to prevent inter-group contamination. Participants admitted between March and April 2025 were assigned to the control group, and those admitted between May and June 2025 were assigned to the intervention group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-fen Feng, Henan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677085
- Sponsor's protocol ID
- HUSOM2025-513
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy restrictions imposed by the Institutional Ethics Committee, and because informed consent obtained from participants did not include provisions for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT07677085
- Acronym / sponsor ID
- HUSOM2025-513
- Conditions
- Peritoneal Dialysis (PD), Frailty Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Henan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 30 Jun 2026 (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 to evaluate the effects of a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC) on patients undergoing peritoneal dialysis with frailty syndrome.
The main questions it aims to answer include:
Can the ITHBC-based comprehensive nursing intervention improve patients' frailty status?
Can the intervention reduce patients' nutritional risk?
Can the intervention enhance patients' exercise self-efficacy, social support, and self-management behaviors?
Researchers will compare the ITHBC-based comprehensive nursing intervention (intervention group) with routine care (control group) to assess the effectiveness of the intervention program.
Participants:
The intervention group receives the ITHBC-based comprehensive nursing intervention (including personalized assessment, knowledge and belief reinforcement, skill development, goal setting and follow-up, and social support promotion) in addition to routine care for 3 months
The control group receives routine care (including admission education, standardized in-hospital health education, and monthly outpatient or telephone follow-up for 3 months)
Data are collected at baseline (T0), 1 month (T1), and 3 months (T2) post-intervention
Outcome measures include: frailty scores, nutritional risk scores, exercise self-efficacy scores, social support scores, and self-management behavior scores
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a quasi-experimental study using temporal (sequential) grouping to prevent inter-group contamination. Participants admitted between March and April 2025 were assigned to the control group, and those admitted between May and June 2025 were assigned to the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ITHBC-Based Comprehensive Nursing InterventionParticipants in this arm received a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to routine care. The intervention consisted of five phases: personalized assessment, knowledge and belief reinforcement, skill and competency development, goal setting and follow-up, and social support promotion, delivered over a 3-month period. |
| Control Group | Active comparator | Behavioral: Routine CareParticipants in this arm received routine care, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- a diagnosis of end-stage renal disease with an estimated glomerular filtration rate of < 15 mL/min/1.73 m² ;
- currently undergoing peritoneal dialysis with regular follow-up at the peritoneal dialysis clinic;
- a score of ≥ 3 on the Fried Frailty Phenotype Scale;
- provision of written informed consent and voluntary participation in this study.
Key exclusion criteria (3 listed)
- presence of concurrent severe primary diseases, including malignant tumors;
- cognitive impairment or a diagnosed mental illness;
- limb dysfunction that precluded cooperation with the intervention.
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 |
|---|---|---|
| ITHBC-Based Comprehensive Nursing InterventionA 3-month comprehensive nursing program based on the Integrated Theory of Health Behavior Change (ITHBC), consisting of five phases: (1) personalized assessment of frailty, nutritional status, physical activity, social support, and self-management capabilities; (2) knowledge and belief reinforcement through video-based and handbook-based education; (3) skill and competency development in nutrition management, multicomponent exercise training, and medication guidance; (4) goal setting and follow-up with individualized diet and exercise plans, biweekly visits in the first month and monthly visits thereafter; and (5) social support promotion involving healthcare professionals, family members, and peer support groups. | Behavioural | Experimental |
| Routine CareRoutine nursing care for PD patients, including admission education, standardized in-hospital health education, and either outpatient or telephone follow-up once monthly for 3 months post-discharge. | Behavioural | Control Group |
Primary outcome
Fried Frailty Phenotype Scale
Time frame: Baseline, Month 1, Month 3
The Fried Frailty Phenotype Scale was developed by Fried et al. in 2001 and is recognized as the most widely used frailty assessment tool in the fields of gerontology and nephrology. This scale includes five components: unintentional weight loss, exhaustion, reduced grip strength, slow walking speed, and decreased physical activity. One point is assigned for each criterion that is met, yielding a total score that ranges from 0 to 5. A score of 0 indicates absence of frailty; scores of 1-2 suggest pre-frailty; and scores of 3 or more indicate frailty. The Cronbach's α coefficient for this scale was reported as 0.868.
Chronic Kidney Disease Self-Management Scale
Time frame: Baseline, Month 1, Month 3
The Chronic Kidney Disease Self-Management Scale (CKD-SM), which was developed by Yu P. and colleagues, evaluates the self-management behavior level of patients undergoing home-based peritoneal dialysis. This scale contains 31 items, which cover four domains: dietary management (12 items), treatment management (9 items), physical activity management (5 items), and psychosocial management (5 items). Each item was scored on a 4-point Likert scale, with response options ranging from "never" to "always" and corresponding scores ranging from 1 to 4. The total score ranges from 31 to 124, with higher scores indicating stronger self-management abilities. The overall Cronbach's α coefficient of this scale was reported as 0.902, and the test-retest reliability was reported as 0.898.
4 secondary outcomes
Nutritional Risk Screening Tool
Time frame: Baseline, Month 1, Month 3
Self-Efficacy for Exercise Scale
Time frame: Baseline, Month 1, Month 3
Social Support Rating Scale
Time frame: Baseline, Month 1, Month 3
Laboratory Parameters
Time frame: Baseline, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy restrictions imposed by the Institutional Ethics Committee, and because informed consent obtained from participants did not include provisions for data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITHBC-Based Comprehensive Nursing Intervention and Routine Care in people with Peritoneal Dialysis (PD) and Frailty Syndrome, run by Henan University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fried Frailty Phenotype Scale (time frame: Baseline, Month 1, Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.