Chronic Renal DiseaseCRISS-MADENCT04940819
A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients
A study testing Mobile Application for Dietary Management in people with Chronic Renal Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a multi-center randomized controlled study. This study aims to investigate the acceptability and efficacy of a newly developed mobile application in the dietary management of chronic kidney disease (CKD) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Mobile Application for Dietary Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,863 participants
- Where
- 1 siteChina
- Study dates
- Jun 2021to Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with CKD for more than 3 months
- Objective measures of kidney disease (fulfill one of the following): 1) eGFR≤60ml/min/1.73m^2; 2) Proteinuria (Protein + on dipstick or 24 hour urine protein>0.3g or albumin-to-creatinine ratio (ACR) >30mg/mmol or protein-to-creatinine ratio (PCR) >50mg/mmol); 3) Imaging proven kidney disease (Atrophy, stone formation, cystic kidney disease, or other structural abnormality)
- Having access to a mobile phone and is capable of using the dietary intervention application
Who cannot join
- Can not provide history of kidney disease or can not provide laboratory result for the past 3 month
- Can not use a mobile phone or deemed unfit to participate by their treating nephrologist
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xixi Zheng, MD, +8613521145030, zxxpumch@163.com
Peng Xia, MD, +8613811684903, 7-xp@163.com
About this study
Official title: A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients: a Multi-Center Randomized Controlled Study
This is a multi-center randomized controlled study. This study aims to investigate the acceptability and efficacy of a newly developed mobile application in the dietary management of chronic kidney disease (CKD) patients.
Read the detailed description
The prevalence of CKD has reached 10.8% in China. Increasing in prevalence of other non-communicable disease such as hypertension, diabetes and obesity is contributing to this rise in CKD and end-stage renal disease prevalence. Diet is a strong modifiable factor in these diseases. Dietary control is also an integral part in CKD disease self management. However, the complexity in the dietary management of CKD makes it hard for patients to adequately self manage. With the development of smart phone, many mobile applications have been developed to suit the need of patients with chronic diseases. But there has been a scarce of randomized trial to support the feasibility, acceptability and efficacy of these mobile applications.
Our study aims to employ a newly developed dietary logging and monitoring application in the primary care setting of CKD patients to test its acceptability and efficacy in disease control.
The application is developed by a multidisciplinary team in a tertiary care center. The main features include searching and logging foods, receiving realtime feedback on key nutrient intake levels and facilitating patient-care giving communication.
We plan to enroll 14 tertiary hospitals and 42 secondary hospitals in 7 geographical regions in China aiming to reach participants in resource poor areas. Participants will be randomized with 1 to 1 ratio to either receiving mobile application dietary intervention or usual dietary consultation. The planned intervention period is 3 months. We will monitor biochemical parameters relating to dietary control and evaluate patient-centered outcomes concerning CKD self management and control.
- Conditions
- Chronic Renal Disease
- Being tested
- Mobile Application for Dietary Management
- Keywords
- Chronic Renal Disease, Dietary Management, Mobile Application
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application for Dietary ManagementBehavioural
A mobile application developed by a multi-disciplinary team will be used in the dietary management of CKD patients. The application is patient orientated. It has 4 core features including food searching, dietary logging, personalized key nutrient intake feedback and patient-caregiver interaction.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Intervention | Experimental | Participants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care. Receives: Behavioral: Mobile Application for Dietary Management |
| Care as Usual | No intervention | Participants in this arm will receive usual CKD dietary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake
Dietary intake of calorie, protein, sodium, potassium and phosphate evaluated by three-day diet records (3DDR)
Measured: 3 months
Diet Quality
Calculated by Chinese Healthy Eating Index
Measured: 3 months
Blood Pressure
Measure BP in office visits after the intervention period. Changes in antihypertensive medication requirements (total number, dose, class) will be collected from participants and verified with hospital records.
Measured: 3 months
change in estimated Glomerular Filtration Rate (eGFR)
blood draw (fasting) before and after intervention period
Measured: 3 months
Change in Proteinuria
spot urine before and after intervention period
Measured: 3 months
Change in Disease Related Quality of life
Measured by Kidney Disease Quality of Life 36-Short Form questionnaire
Measured: 3 months
Change in Self-Efficacy for Managing Chronic Disease Scale
Score of Self-Efficacy for Managing Chronic Disease Scale (6 items, each measured on a 1-10 likert scale, higher score indicate better self-efficacy) before and after intervention period
Measured: 3 months
Change in Perceived Medical Condition Self-Management Scale (PMCSMS）
Measured by Perceived Medical Condition Self-Management Scale (8-item CKD-specific version of the PMCSMS, each item is scored on a 1-5 likert scale, with higher score indicating better self management on item 3/4/5/8 and lower score indicating better self management on item 1/2/6/7) before and after intervention
Measured: 3 months
Secondary outcomes (9)
Blood Chemistry (Potassium, Bicarbonate, Phosphate)
blood draw (fasting) before and after intervention period
Measured: 3 months
Urine Sodium/potassium Ratio
Measured by spot urine at baseline and after intervention
Measured: 3 months
Salt Taste Threshold
Salt taste threshold measured using salt-impregnated test strips before and after the intervention period
Measured: 3 months
Kidney Nutrition Knowledge, Attitude and Practice
Measured by self developed questionnaire about knowledge, attitude and practice in kidney disease specified diet
Measured: 3 months
Acceptability of the Application
Measured by user acceptability survey and semistructured interviews conducted in participants and nephrologists
Measured: 3 months
Adherence
Total number of diet diary logged by participants over complete study period (more than 60% logged is deemed good adherence)
Measured: 3 months
Adoption
Measured by percentage of complete dietary log in days will be counted (>1200kcal deemed as complete log)
Measured: 3 months
Change in the score of Generalized Anxiety Disorder Scale
Measured by Generalized Anxiety Disorder Scale (a 7-item self-report scale. Items are rated on a 4-point Likert-scale with 0 = not at all to 3 = nearly every day ) before and after intervention
Measured: 3 months
Change in the score of Hospital Anxiety and Depression Scale
Measured by Hospital Anxiety and Depression Scale (14 items each rated on a 0-3 score, with higher score indicating worse anxiety or depression symptoms) before and after intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,863 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limeng Chen, Peking Union Medical College Hospital
- Investigators
- Limeng Chen, MD, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940819
- Sponsor's protocol ID
- CRISS-Diet
- Acronym
- CRISS-MADE
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
PubMed 22386035Stevenson JK, Campbell ZC, Webster AC, Chow CK, Tong A, Craig JC, Campbell KL, Lee VW. eHealth interventions for people with chronic kidney disease. Cochrane Database Syst Rev. 2019 Aug 6;8(8):CD012379. doi: 10.1002/14651858.CD012379.pub2.
PubMed 31425608Lim JH, Lim CK, Ibrahim I, Syahrul J, Mohamed Zabil MH, Zakaria NF, Daud ZAM. Limitations of Existing Dialysis Diet Apps in Promoting User Engagement and Patient Self-Management: Quantitative Content Analysis Study. JMIR Mhealth Uhealth. 2020 Jun 1;8(6):e13808. doi: 10.2196/13808.
PubMed 32478665
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application Based Dietary Self Management Intervention in Chinese Chronic Kidney Disease Patients: a Multi-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04940819
- Acronym / sponsor ID
- CRISS-MADE / CRISS-Diet
- Conditions
- Chronic Renal Disease
- Keywords
- Chronic Renal Disease, Dietary Management, Mobile Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,863 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Jun 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.
This is a multi-center randomized controlled study. This study aims to investigate the acceptability and efficacy of a newly developed mobile application in the dietary management of chronic kidney disease (CKD) patients.
Detailed description
The prevalence of CKD has reached 10.8% in China. Increasing in prevalence of other non-communicable disease such as hypertension, diabetes and obesity is contributing to this rise in CKD and end-stage renal disease prevalence. Diet is a strong modifiable factor in these diseases. Dietary control is also an integral part in CKD disease self management. However, the complexity in the dietary management of CKD makes it hard for patients to adequately self manage. With the development of smart phone, many mobile applications have been developed to suit the need of patients with chronic diseases. But there has been a scarce of randomized trial to support the feasibility, acceptability and efficacy of these mobile applications.
Our study aims to employ a newly developed dietary logging and monitoring application in the primary care setting of CKD patients to test its acceptability and efficacy in disease control.
The application is developed by a multidisciplinary team in a tertiary care center. The main features include searching and logging foods, receiving realtime feedback on key nutrient intake levels and facilitating patient-care giving communication.
We plan to enroll 14 tertiary hospitals and 42 secondary hospitals in 7 geographical regions in China aiming to reach participants in resource poor areas. Participants will be randomized with 1 to 1 ratio to either receiving mobile application dietary intervention or usual dietary consultation. The planned intervention period is 3 months. We will monitor biochemical parameters relating to dietary control and evaluate patient-centered outcomes concerning CKD self management and control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Intervention | Experimental | Behavioral: Mobile Application for Dietary ManagementParticipants in this arm will receive mobile application dietary intervention as well as usual CKD dietary care. |
| Care as Usual | No intervention | –Participants in this arm will receive usual CKD dietary care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with CKD for more than 3 months
- Objective measures of kidney disease (fulfill one of the following): 1) eGFR≤60ml/min/1.73m^2; 2) Proteinuria (Protein + on dipstick or 24 hour urine protein>0.3g or albumin-to-creatinine ratio (ACR) >30mg/mmol or protein-to-creatinine ratio (PCR) >50mg/mmol); 3) Imaging proven kidney disease (Atrophy, stone formation, cystic kidney disease, or other structural abnormality)
- Having access to a mobile phone and is capable of using the dietary intervention application
Key exclusion criteria (2 listed)
- Can not provide history of kidney disease or can not provide laboratory result for the past 3 month
- Can not use a mobile phone or deemed unfit to participate by their treating nephrologist
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 |
|---|---|---|
| Mobile Application for Dietary ManagementA mobile application developed by a multi-disciplinary team will be used in the dietary management of CKD patients. The application is patient orientated. It has 4 core features including food searching, dietary logging, personalized key nutrient intake feedback and patient-caregiver interaction. | Behavioural | Mobile Application Intervention |
Primary outcome
Dietary Intake
Time frame: 3 months
Dietary intake of calorie, protein, sodium, potassium and phosphate evaluated by three-day diet records (3DDR)
Diet Quality
Time frame: 3 months
Calculated by Chinese Healthy Eating Index
Blood Pressure
Time frame: 3 months
Measure BP in office visits after the intervention period. Changes in antihypertensive medication requirements (total number, dose, class) will be collected from participants and verified with hospital records.
change in estimated Glomerular Filtration Rate (eGFR)
Time frame: 3 months
blood draw (fasting) before and after intervention period
Change in Proteinuria
Time frame: 3 months
spot urine before and after intervention period
Change in Disease Related Quality of life
Time frame: 3 months
Measured by Kidney Disease Quality of Life 36-Short Form questionnaire
Change in Self-Efficacy for Managing Chronic Disease Scale
Time frame: 3 months
Score of Self-Efficacy for Managing Chronic Disease Scale (6 items, each measured on a 1-10 likert scale, higher score indicate better self-efficacy) before and after intervention period
Change in Perceived Medical Condition Self-Management Scale (PMCSMS）
Time frame: 3 months
Measured by Perceived Medical Condition Self-Management Scale (8-item CKD-specific version of the PMCSMS, each item is scored on a 1-5 likert scale, with higher score indicating better self management on item 3/4/5/8 and lower score indicating better self management on item 1/2/6/7) before and after intervention
9 secondary outcomes
Blood Chemistry (Potassium, Bicarbonate, Phosphate)
Time frame: 3 months
Urine Sodium/potassium Ratio
Time frame: 3 months
Salt Taste Threshold
Time frame: 3 months
Kidney Nutrition Knowledge, Attitude and Practice
Time frame: 3 months
Acceptability of the Application
Time frame: 3 months
Adherence
Time frame: 3 months
Adoption
Time frame: 3 months
Change in the score of Generalized Anxiety Disorder Scale
Time frame: 3 months
Change in the score of Hospital Anxiety and Depression Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 22386035Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
- Background: PubMed 31425608Stevenson JK, Campbell ZC, Webster AC, Chow CK, Tong A, Craig JC, Campbell KL, Lee VW. eHealth interventions for people with chronic kidney disease. Cochrane Database Syst Rev. 2019 Aug 6;8(8):CD012379. doi: 10.1002/14651858.CD012379.pub2.
- Background: PubMed 32478665Lim JH, Lim CK, Ibrahim I, Syahrul J, Mohamed Zabil MH, Zakaria NF, Daud ZAM. Limitations of Existing Dialysis Diet Apps in Promoting User Engagement and Patient Self-Management: Quantitative Content Analysis Study. JMIR Mhealth Uhealth. 2020 Jun 1;8(6):e13808. doi: 10.2196/13808.
- 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.
Limeng Chen, MD, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application for Dietary Management in people with Chronic Renal Disease, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 2 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 28 Jun 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 China. 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 Xixi Zheng, MD (+8613521145030, zxxpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Intake (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940819, which also lists 3 linked publications.
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 28 Jun 2021.