A randomized controlled trial to assess the efficacy of nurse led interventions on adherence to dietary and fluid restrictions and other health related outcomes among patients with chronic kidney disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Self reported adherence
Study Overview
Brief Summary
The objective of this study is to evaluate theefficacy of nurse lead interventions on adherence to dietary and fluidrestrictions and other health related outcomes among patients with chronickidney disease. Hemodialysis patients, who fulfill inclusion andexclusion criteria, will be enrolled for the study as study participants andthey will be randomized into control and intervention group. Nurse led interventionwill be implemented in the intervention group. Outcome measures will becollected at base line and at 6th and 10th week afterintervention. This theory based Nurse led intervention trial designed up onvigorous review of previous research emphasizing the importance of nursespecific interventions to empower patients and enable them to be adherent withtheir treatment regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •To have a medical diagnosis of CKD and undergoing maintenance hemodialysis To be aged between 20 and 80 years old Receiving hemodialysis at least for last three consecutive months To have a mobile connection To be able to read and understand Malayalam/Tamil/English.
Exclusion Criteria
- •Not willing to participate in intervention A diagnosis of functional psychosis or organic brain disorder Impaired cognition Major visual or hearing impairments, or other sensory or motor impairments that may prohibit completion of the scheduled assessments Limited life expectancy.
Outcomes
Primary Outcomes
Self reported adherence
Time Frame: Baseline and at 6th and 10th week of post intervention in both groups
Biological and biochemical measures of adherence
Time Frame: Baseline and at 6th and 10th week of post intervention in both groups
Secondary Outcomes
- Dialyis & CKD related morbidities(Quality Of Life)