Effect of Behavioral Intervention on Interdialytic Weight Gain in Patients Undergoing Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Effect of Text Messages on Dietary Salt and Fluid Restriction on Inter-dialytic Weight Gain in Hemodialysis Patients: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892225
• Other study ID #: FHWWMRCT0001
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: May 2021
• Source: Farooq Hospital - West Wood Branch
• Contact: Salman Tahir Shafi, MBBS
• Phone: +92 306 4000 715
• Email: salmanshafi[@]email.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Mortality among hemodialysis (HD) patients remains high with cardiovascular causes accounting for more than one-third of mortality in incident and prevalent end-stage renal disease (ESRD) patients. One factor contributing to poor cardiovascular outcomes is chronic volume overload ,which is a function of excess fluid intake in relation to residual renal function and fluid removal with dialysis treatments. Interdialytic weight gain (IDWG) is an easily measurable parameter in the dialysis unit, routinely assessed at the beginning of the dialysis session. Very few studies have been designed to determine the direct effect of IDWG on morbidity and mortality. Any such effect is confounded by residual renal function and various comorbidities, the effects of which might be difficult to separate from those of IDWG. Most attempts to control IDWG have concentrated on requiring patients to reduce fluid and dietary salt intake. Inter-dialytic weight gain is the result of salt and water intake between 2 hemodialysis sessions. Interdialytic weight gain (IDWG) is commonly used as an indirect measure of fluid intake in HD patients, while considering the daily urine output of the patient. It is used along with clinical symptoms and signs and predialysis blood pressure readings to make decisions regarding the amount of fluid removal during a dialysis session. IDWG is also used as a basis for fluid and salt intake recommendations. High IDWG has detrimental effects on survival, cardiovascular outcomes, and quality of life. A higher IDWG is associated with higher predialysis systolic and diastolic blood pressure ,uncontrolled hypertension which contributes to left ventricular hypertrophy, increasing intradialytic hypotension as a result of higher ultrafiltration rates , and increased morbidity and mortality.

High IDWG is due to poor adherence to fluid restriction and to excessive intake of fluids. Various strategies and interventions have been proposed to control IDWG such as the reduction of dietary salt intake, behavioral interventions aimed at improving the adherence to fluid restriction, the improvement of xerostomia, and the use of lower dialysate sodium concentration. Despite the severe consequences of non-adherence, it has been estimated that 30%-60% of hemodialysis patients do not adhere to a fluid intake guidelines. Various restrictions and barriers such as psychological (low motivation) or social (inadequate support from family, friends), lack of knowledge (lack of understanding of what they were advised), and lack of self-assessment (being unable to judge overall fluid status, fluid intake, or salt consumption) have been shown to be related to failed adherence to fluid restriction strategy. Strategies of behavioral intervention have been used to improve adherence to fluid restriction and to limit IDWG. These strategies aimed to improve motivation, knowledge, social support and education of hemodialysis patients. The behavioral interventions generally used included various approaches, such as behavioral contracting and weekly telephone contacts with patients, patient self-monitoring and behavioral contracting upon adherence, stepped verbal and written reinforcement, group-administered behavioral self-regulation intervention, group education sessions based on trans-theoretical model (states of change), self-efficacy training, and group or individual cognitive behavioral therapy. Numerous randomized controlled studies have been performed, but unfortunately, their results conflict and cannot permit conclusive considerations. It is difficult to compare such studies because of the differences in terms of duration and sample size. Consequently, it is hard to define if certain behavioral interventions are more effective than others. However, what emerges is that the behavioral intervention, although leading to a positive outcome, is temporary and has limited long-term effectiveness. Modest evidence suggests that behavioral intervention strategies (e.g., instruction in self-monitoring, behavioral contracting, and positive reinforcement) may be associated with improved adherence among hemodialysis patients.

The purpose of this behavioral study was to evaluate the efficacy of a technology-supported behavioral intervention (text message) for reducing IDWGs and dietary sodium intake in patients undergoing intermittent HD. The investigators have devised a relatively simplified behavioral intervention(a simple text message regarding fluid and salt restriction) as it will be easier and less cumbersome to perform owing to the educational status and level of understanding of the local population. Moreover, it is less expensive as compared to other interventions and less complicated. Another study which used text message as medium of communication depicted that smoking quit rates for the text messaging intervention group were 36% higher compared to the control group quit rates. Results also suggested that SMS text messaging technology might be a promising way to improve smoking cessation outcomes. This is significant given the relatively wide reach and low cost of text message interventions. Identifying the components that make interventions efficacious will help to increase the effectiveness of such interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 15, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Weight Gain

Intervention

Behavioral:
• Technology-supported behavioral intervention (text message)
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.

Locations

Country	Name	City	State
Pakistan	Farooq Hospital West Wood Branch	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Farooq Hospital - West Wood Branch

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mean inter-dialytic weight gain	Comparison of change in mean inter-dialytic weight gain from baseline between two groups at end of 4 week and 8 week period. Average inter-dialytic weight over last week will be used for comparison.	8 weeks
Secondary	Proportion of patients with high inter-dialytic weight gain	Comparison of proportion of patients with high inter-dialytic weight gain (defined as >4% of dry weight) between two groups at end of 4 week and 8 week period. Average inter-dialytic weight over last week will be used for comparison.	8 weeks
Secondary	Comparison of pre-dialysis systolic and diastolic blood pressure	Comparison of Pre-dialysis Systolic and Diastolic Blood Pressure between two groups at end of study of 4 week and 8 week period. Average Pre-dialysis Systolic and Diastolic Blood Pressures over last week will be used for comparison.	8 weeks

External Links

•   A Cognitive Behavioral Group Approach to Enhance Adherence to Hemodialysis Fluid Restrictions: A Randomized Controlled Trial
•   A comparison of attributions, health beliefs, and negative emotions as predictors of fluid adherence in renal dialysis patients: A prospective analysis
•   Blood pressure and long-term mortality in United States hemodialysis patients: USRDS Waves 3 and 4 Study1
•   Differences in Knowledge, Stress, Sensation Seeking, and Locus of Control Linked to Dietary Adherence in Hemodialysis Patients
•   Disentangling the Ultrafiltration Rate-Mortality Association: The Respective Roles of Session Length and Weight Gain
•   Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial
•   Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial
•   Fellows' Forum in Dialysis: Interdialytic Weight Gain: Implications in Hemodialysis Patients
•   Greater Fluid Retention is Associated with Increased Cardiovascular Mortality in Different Groups of CKD Patients on Hemodialysis
•   Impact of hypertension on cardiomyopathy, morbidity and mortality in end-stage renal disease
•   Impact of stepped verbal and written reinforcement of fluid balance advice within an outpatient haemodialysis unit: a pilot study
•   Interdialytic weight gain and ultrafiltration rate in hemodialysis: Lessons about fluid adherence from a national registry of clinical practice
•   Interdialytic weight gain as a marker of blood pressure, nutrition, and survival in hemodialysis patients
•   Patient Perspectives on Fluid Management in Chronic Hemodialysis
•   Psychosocial Intervention Improves Depression, Quality of Life, and Fluid Adherence in Hemodialysis
•   Relation between Interdialytic Weight Gain, Body Weight and Nutrition in Hemodialysis Patients
•   Relationship Between Interdialytic Weight Gain and Blood Pressure Among Prevalent Hemodialysis Patients
•   Self-efficacy training for patients with end-stage renal disease
•   Stages of change and fluid intake in dialysis patients
•   The effect of a self-monitoring tool on self-efficacy, health beliefs, and adherence in patients receiving hemodialysis
•   The Effect of Psychological Intervention on Thirst and Interdialytic Weight Gain in Patients on Chronic Hemodialysis: A Randomized Controlled Trial
•   The mortality risk of overhydration in haemodialysis patients
•   The Relationship Between Social Support and Adherence of Dietary and Fluids Restrictions among Hemodialysis Patients in Iran
•   Variability of Predialytic, Intradialytic, and Postdialytic Blood Pressures in the Course of a Week: A Study of Dutch and US Maintenance Hemodialysis Patients