Impact of Caregiver Empowerment Module on the Quality of Life and Medication Adherence in the Children with Idiopathic Nephrotic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- 1. Change in quality of life of children with idiopathic nephrotic syndrome (INS), measured using a pediatric quality of life questionnaire.
Study Overview
Brief Summary
The randomized controlled trial aims to evaluate the impact of the Caregiver Empowerment Module on the quality of life and medication adherence among children (aged 2–12 years) diagnosed with steroid-sensitive nephrotic syndrome (SSNS), including frequently relapsing, infrequently relapsing, and steroid-dependent cases. The intervention group caregivers will receive a structured educational module comprising a booklet, PowerPoint presentations, demonstrations, and discussions delivered in four sessions over 2 months, followed by fortnightly telephonic follow-up for six months. The module includes disease understanding, treatment adherence, urine dipstick monitoring, relapse identification, and diary maintenance. The control group will receive routine care. Outcomes will be assessed at baseline, 3 months, and 6 months. In addition to quality of life and medication adherence, secondary outcomes include caregiver knowledge and practice, time to first relapse, and time to initiation of prednisolone therapy after relapse. The study will also examine correlations and associations between adherence, quality of life, and selected demographic and clinical variables.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 2.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children with SSNS including Frequently Relapsing Nephrotic Syndrome (FRNS), Infrequent Relapsing Nephrotic syndrome (IFRNS), Steroid Dependence Nephrotic Syndrome (SDNS) and their primary caregivers those who can understand hindi or english language.
Exclusion Criteria
- •Children with Steroid resistant Nephrotic Syndrome (SRNS), congenital Nephrotic syndrome, Secondary Nephrotic syndrome and their caregivers.
Outcomes
Primary Outcomes
1. Change in quality of life of children with idiopathic nephrotic syndrome (INS), measured using a pediatric quality of life questionnaire.
Time Frame: 3 months and 6 months after completion of Caregiver Empowerment Module
2. Change in medication adherence in children with idiopathic Nephrotic Syndrome, assessed using Morisky Medication Adherence Scale
Time Frame: 3 months and 6 months after completion of Caregiver Empowerment Module
Secondary Outcomes
- Change in the knowledge and practice scores of the caregivers of the children with nephrotic syndrome(3 months and 6 months after completion of Caregiver Empowerment module)
- correlation between medication adherence and Quality of Life in children with nephrotic syndrome(3 months and 6 months after completion of Caregiver Empowerment module)
- Association of quality of life and medication adherence with selected demographic and clinical variables.(3 months and 6 months after completion of the Caregiver Empowerment Module)
- Time to first relapse after enrollment during the study period.(continously monitored for 6 months following completion of caregiver Empowerment Module)
- Time of initiation of Prednisolone therapy at(60 mg/m²/day following relapse during study period)