NCT04892225

Brief Summary

A randomized clinical trial will be conducted in which effect of behavioral intervention (Text message of dietary salt and fluid restriction) on inter-dialytic weight gain in hemodialysis patients. The purpose of this is to evaluate the efficacy of a technology supported intervention for reducing inter-dialytic weight gain and dietary sodium intake in patients undergoing intermittent hemodialysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 10, 2021

Last Update Submit

May 17, 2021

Conditions

End Stage Renal Disease

Keywords

Inter-dialytic weight gainFluid and salt restrictionBehavioral interventionHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Mean inter-dialytic weight gain

    Comparison of mean inter-dialytic weight gain between two groups at the end of 4 week and 8 week period. Average inter-dialytic weight over last week will be used for comparison.

    8 weeks

Secondary Outcomes (3)

  • Change in mean inter-dialytic weight gain

    8 weeks

  • Proportion of patients with high inter-dialytic weight gain

    8 weeks

  • Comparison of pre-dialysis systolic and diastolic blood pressure

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Individuals in this group will be randomly assigned to text message in Urdu language on dietary sodium and fluid restriction daily for 8 weeks.

Behavioral: Technology-supported behavioral intervention (text message)

Control group

NO INTERVENTION

Randomly assigned Control group will not receive any text message.

Interventions

Technology-supported behavioral intervention (text message)BEHAVIORAL

A simple text message regarding the salt and fluid restriction in order to reduce the inter-dialytic weight gain will be send on daily basis to all the individuals in the intervention group.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above 18 years of age
  • Patients with End stage renal disease and on maintenance hemodialysis at least twice a week for at least 1 month
  • Patients or immediate family members have access to mobile phones
  • Patients are able to read and understand text message in urdu language

You may not qualify if:

  • Patients with terminal illness and limited life expectancy of less than 1 month
  • Patients with Dementia
  • Patients with visual impairment
  • Patients with Acute Kidney injury requiring hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farooq Hospital West Wood Branch

Lahore, Punjab Province, 53700, Pakistan

RECRUITING

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Salman Tahir Shafi, MBBS

CONTACT

+92 306 4000 715salmanshafi@email.com

Omair Farooq, MBBS

CONTACT

+92 321 8890 819omairfarooq@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned to text message in Urdu language on dietary sodium and fluid restriction daily for 8 weeks. Control group will not receive any text message.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Nephrologist

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

April 30, 2021

Primary Completion

July 1, 2021

Study Completion

July 15, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)