ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2014/08/004900
Date of registration:	20-08-2014
Prospective Registration:	No
Primary sponsor:	Manipal University
Public title:	Impact of Pharmaceutical Care on Quality of Life among Chronic Kidney Disease Patients on Hemodialysis
Scientific title:	Impact of Pharmaceutical Care Plan on Health Related Quality of Life and Pharmacoeconomic Studies among Chronic Kidney Disease Patients on Hemodialysis- A Multicentric study
Date of first enrolment:	15-03-2014
Target sample size:	200
Recruitment status:	Closed to Recruitment of Participants
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8802
Study type:	Interventional
Study design:	Randomized, Parallel Group Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
Phase:	N/A

Countries of recruitment
India

Contacts

Name:	Anantha Nagappa Naik
Address:	Dept. of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India. E-mail: anantha.naik@manipal.edu anantha1232000@gmail.com Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India. E-mail: 576104 Udupi, KARNATAKA India
Telephone:	9900407416
Email:	anantha1232000@gmail.com
Affiliation:	Manipal College of Pharmaceutical Sciences, Manipal University

Name:	Anantha Nagappa Naik
Address:	Dept. of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India. E-mail: anantha.naik@manipal.edu Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India. E-mail: anantha.naik@manipal.edu 576104 Udupi, KARNATAKA India
Telephone:	9900407416
Email:	anantha1232000@gmail.com
Affiliation:	Manipal College of Pharmaceutical Sciences, Manipal University

Key inclusion & exclusion criteria

Inclusion criteria: CKD patients on hemodialysis who are in the outpatient category

Patients who are on hemodialysis at least for last 3 months

The patients with a history of regular visits for hemodialysis

ï?? Age bracket from 18-75 years

Exclusion criteria: Patients who are not willing to participate in the study

Patients with psychiatric illness history

Pregnant women

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic Kidney disease patients on Hemodialysis

Intervention(s)

Intervention1: Interventional Trial - Randomized controlled Trial: Intervention Group: Consists of CKD patients on hemodialysis. They shall receive the standard care along with Pharmaceutical Care delivered by qualified clinical pharmacist. The Pharmaceutical Care emphasizes the motivation and education which are validated protocols regarding knowledge about the disease, medication and Life style changes, personal interview, medication review, and recommended actions.
The duration of study is 12 months followup.

Control Intervention1: Control Group: Control Group: Consists of CKD patients on hemodialysis patients who will be given the standard care by the hospital staff like physicians and nurses.
The duration of study is 12 months followup.

Primary Outcome(s)

Improvement in Health Related Quality of Life as per the Kidney Disease Quality of Life among CKD patients on Hemodialysis in interventional group and control group for 12 months.Timepoint: 0, 06, 12 months

Secondary Outcome(s)

Secondary outcomes includes: Measurement and evaluation of medication adherence, hospitalization rates, morality rate, Intra-dialytic weight gain, Blood pressure, complications and Cost of the medications.Timepoint: 0, 06, 12 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Manipal University under structured Ph.D program

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 09/04/2013
Contact:

Institutional ethics committee, Manipal, Kasturba Hospital

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.