End Stage Renal DiseaseNCT04892225
Effect of Behavioral Intervention on Interdialytic Weight Gain in Patients Undergoing Hemodialysis
A study testing Technology-supported behavioral intervention (text message) in people with End Stage Renal Disease, run by Farooq Hospital - West Wood Branch at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Technology-supported behavioral intervention (text message)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Farooq Hospital West Wood Branch
Lahore, Punjab Province, 53700
Salman Tahir Shafi, MBBS, +92 306 4000 715, salmanshafi@email.com
Omair Farooq, MBBS, +92 321 8890 819, omairfarooq@hotmail.com
About this study
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
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.
Read the detailed 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Technology-supported behavioral intervention (text message)
- Keywords
- Inter-dialytic weight gain, Fluid and salt restriction, Behavioral intervention, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-supported behavioral intervention (text message)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Technology-supported behavioral intervention (text message) |
| Control group | No intervention | Randomly assigned Control group will not receive any text message. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start30 Apr 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farooq Hospital - West Wood Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Salman Tahir Shafi, Farooq Hospital - West Wood Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892225
- Sponsor's protocol ID
- FHWWMRCT0001
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04892225
- Acronym / sponsor ID
- FHWWMRCT0001
- Conditions
- End Stage Renal Disease
- Keywords
- Inter-dialytic weight gain, Fluid and salt restriction, Behavioral intervention, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Farooq Hospital - West Wood BranchUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Technology-supported behavioral intervention (text message)Individuals in this group will be randomly assigned to text message in Urdu language on dietary sodium and fluid restriction daily for 8 weeks. |
| Control group | No intervention | –Randomly assigned Control group will not receive any text message. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Mean inter-dialytic weight gain
Time frame: 8 weeks
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.
3 secondary outcomes
Change in mean inter-dialytic weight gain
Time frame: 8 weeks
Proportion of patients with high inter-dialytic weight gain
Time frame: 8 weeks
Comparison of pre-dialysis systolic and diastolic blood pressure
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Relationship Between Interdialytic Weight Gain and Blood Pressure Among Prevalent Hemodialysis PatientsLink provided by the sponsor.
- Disentangling the Ultrafiltration Rate-Mortality Association: The Respective Roles of Session Length and Weight GainLink provided by the sponsor.
- A comparison of attributions, health beliefs, and negative emotions as predictors of fluid adherence in renal dialysis patients: A prospective analysisLink provided by the sponsor.
- Differences in Knowledge, Stress, Sensation Seeking, and Locus of Control Linked to Dietary Adherence in Hemodialysis PatientsLink provided by the sponsor.
- The Relationship Between Social Support and Adherence of Dietary and Fluids Restrictions among Hemodialysis Patients in IranLink provided by the sponsor.
- Stages of change and fluid intake in dialysis patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-supported behavioral intervention (text message) in people with End Stage Renal Disease, run by Farooq Hospital - West Wood Branch at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salman Tahir Shafi, MBBS (+92 306 4000 715, salmanshafi@email.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean inter-dialytic weight gain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.