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Home » Trials » SLCTR/2015/030

A study to assess the improvement of management outcomes in Chronic Kidney Disease of Uncertain etiology by introducing clinical pharmacy services to selected out-patient renal clinics in the North Central Province, Sri Lanka

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SLCTR Registration Number

SLCTR/2015/030

Date of Registration

16 Dec 2015

The date of last modification

Mar 03, 2019

View original TRDS

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Trial Status


Application Summary

Scientific Title of Trial

A study to assess the improvement of management outcomes in Chronic Kidney Disease of Uncertain etiology by introducing clinical pharmacy services to selected out-patient renal clinics in the North Central Province, Sri Lanka

Public Title of Trial

Clinical pharmacy services to improve management outcomes of Chronic Kidney Disease of uncertain etiology

Disease or Health Condition(s) Studied

Chronic Kidney Disease of uncertain etiology

Scientific Acronym

None

Public Acronym

None

Brief title

Improving CKDu management outcomes using clinical pharmacy services

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

Faculty of Medicine, Kelaniya ERC: P/148/09/2015


Trial Details

What is the research question being addressed?

Would clinical pharmacy services help to improve selected management outcomes, disease progression and quality of life compared to standard services in CKDu patients attending out-patient renal clinics in the North Central Province?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Health services research

Study Phase

Not Applicable

Intervention(s) planned

The study subjects will be recruited from the patients diagnosed with CKDu Stages 4 and 5, attending out-patient renal clinics in Teaching Hospital, Anuradhapura.

The randomization will be done using the closed envelope method to allocate the participants into two arms.

A trained Sri Lankan pharmacist will provide the following clinical pharmacy services to the participants in the intervention arm during four non-consecutive clinic visits over a period of one year (at recruitment and 2,6 and 10 months)

  1. Individual review of the patients’ drug list (Possible drug related problems will be communicated to the doctor or patient depending on its nature).

  2. Individualized one to one drug counselling for 30 minutes. The non-intervention group will receive standard clinic care.

Inclusion criteria

  1. Consenting adults age over 18 years
  2. Established diagnosis of Stage 3 or 4 Chronic Kidney Disease of Uncertain etiology

Exclusion criteria

  1. Patients undergoing haemodialysis at recruitment
  2. Patients with a history of renal transplantation
  3. Patients who do not give consent

Primary outcome(s)

1.

Drug adherence as measured by the brief medication questionnaire: A tool for screening patient adherence and barriers to adherence (Svarstad et al., 1999)

[

1.At the date of recruitment (baseline) and 12 months after the date of recruitment (post research)

]

Secondary outcome(s)

1.
  1. Blood Pressure
  2. Blood investigations: hemoglobin, serum calcium, serum phosphate, serum creatinine, serum electrolytes
  3. Quality of life as measured by Kidney Disease Quality of Life Short Form (KDQOL-SFTM), Version 1.3. (Hays et al, 1995).
 [
  1. At the date of recruitment (baseline) and 12 months after the date of recruitment (post research)
  2. At the date of recruitment (baseline) and 12 months after the date of recruitment (post research) 3.At the date of recruitment (baseline) and 12 months after the date of recruitment (post research)
]

Target number/sample size

300 (150 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2015-12-16

Anticipated end date

2017-12-16

Date of first enrollment

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

National Research Council of Sri Lanka

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2015-09-08

Approval number

P/148/09/2015

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Shamila T. De Silva
Senior Lecturer in Medicine
Department of Medicine, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
Tel: 0112961119
Mob: 0773601490
Fax: 0112958337
shamiladp@hotmail.com

Contact Person for Public Queries

Nadeesha Dilmi Dias Wickramasinghe
Researcher
Department of Medicine, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
Tel: 0112961119
Mob: 0715399862
Fax: 0112958337
dilmiwickramasinghe2008@gmail.com

Primary study sponsor/organization

National Research Council

No Bauddhaloka Mw, Colombo 07.
Tel: 0112695060
Fax: 0112675136
nrc@sltnet.lk
www.nrc.gov.lk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options