| CTRI Number |
CTRI/2019/06/019894 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led interventions ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of nurse led interventions on adherence to dietary and fluid restrictions and other health related outcomes among patients with chronic kidney disease |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay VR |
| Designation |
Research scholar |
| Affiliation |
RGUHS Bangalore |
| Address |
Mylakkara PO
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
|
| Fax |
|
| Email |
vijayvrpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harmeet Kaur Kang |
| Designation |
Principal |
| Affiliation |
Chitkara university |
| Address |
Chitkara School Of Health Sciences
Chitkara University
Rajpura
Patiala
PUNJAB
140401
India |
| Phone |
|
| Fax |
|
| Email |
harmeet.kaur@chitkara.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Thampi |
| Designation |
Senior Nephrologist |
| Affiliation |
Department of Nephrology NIMS Medicity |
| Address |
NIMS Medicity
Aralummoodu
Neyyattinkara
Thiruvananthapuram
KERALA
695123
India |
| Phone |
|
| Fax |
|
| Email |
drmanjuthampi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded,
Vijay VR,
Rasvi,
Mylakkara PO,
Thiruvananthapuram dist,
Kerala- 695572 |
|
|
Primary Sponsor
|
| Name |
Vijay VR |
| Address |
Rasvi, Mylakkara PO, Thiruvananthapuram, Kerala
PIN- 695572 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Thampi |
Noorul Islam Institute of Medical Science (NIMS) & Research Foundation |
Dialysis Unit,
Department of Nephrology,
Noorul Islam Institute of Medical Science (NIMS) & Research Foundation,
NIMS Medicity,
Aralummoodu PO,
Neyyattinkara,
Thiruvananthapuram Dist,
Kerala- 695123
Thiruvananthapuram
KERALA |
9847101301
drmanjuthampi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led intervention |
Nurse led interventions consist
of nurse led brief advice (NBA),
brief motivational intervention
(BMI), telephonic booster
intervention I & II (TBI I & II) and
daily morning reminder SMS
(R-SMS). Outcome measures
will be assessed during the
baseline assessment and at 6th
and 10th week of post
intervention in both groups |
| Comparator Agent |
Usual standard care |
Usual standard care. Outcome measures will be assessed during the baseline assessment and at 6th and 10th week of post intervention in both groups
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self reported adherence
Biological and biochemical measures of adherence |
Baseline and at 6th and 10th week of post intervention in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dialyis & CKD related morbidities
Quality Of Life
Anxiety and depression
Self efficacy
|
Baseline and at 6th and 10th week of post intervention in both groups |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this study is to evaluate the
efficacy of nurse lead interventions on adherence to dietary and fluid
restrictions and other health related outcomes among patients with chronic
kidney disease. Hemodialysis patients, who fulfill inclusion and
exclusion criteria, will be enrolled for the study as study participants and
they will be randomized into control and intervention group. Nurse led intervention
will be implemented in the intervention group. Outcome measures will be
collected at base line and at 6th and 10th week after
intervention. This theory based Nurse led intervention trial designed up on
vigorous review of previous research emphasizing the importance of nurse
specific interventions to empower patients and enable them to be adherent with
their treatment regimen.
|