Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis

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• Frailty 1,199

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 681 interventional studies indexed under Frailty.

Lead sponsor

Henan University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Study arms

• 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.

  Behavioral: ITHBC-Based Comprehensive Nursing Intervention

• Active comparator
  Control Group

  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.

  Behavioral: Routine Care

Interventions

• BehavioralITHBC-Based Comprehensive Nursing Intervention

  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.

• BehavioralRoutine Care

  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.

Primary outcomes

1. 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.

   Time frame: Baseline, Month 1, Month 3

2. 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.

   Time frame: Baseline, Month 1, Month 3

Secondary outcomes

1. 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.

   Time frame: Baseline, Month 1, Month 3

2. 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

   Time frame: Baseline, Month 1, Month 3

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.

   Time frame: Baseline, Month 1, Month 3

4. Laboratory Parameters

   Serum albumin, hemoglobin, and serum total protein levels were measured to evaluate nutritional status and anemia in patients.

   Time frame: Baseline, Month 3

Individual participant data

Plan to share: 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.