Chronic Kidney DiseasesiControl CKDNCT03951363
iControl Chronic Kidney Disease
A study testing interactive Obesity Treatment Approach (iOTA) in people with Chronic Kidney Diseases, run by Duke University at 1 site in United States.
Trial summary
The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- interactive Obesity Treatment Approach (iOTA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 20 Feb 2020
- 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
- Qualitative interview:
- Age 18 or older
- Diagnosed with CKD (self-report)
- Proficient in English
- Pilot Groups:
- Age 18 or older
Show all 11Show fewer
- Diagnosed with mild to moderate CKD (documented eGFR ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2 )
- Diagnosed with diabetes and/or hypertension
- Proficient in English
- Access to a test-enabled mobile phone
- Willing to receive and send multiple text messages in a week
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Global Digital Health Science Center
Durham, North Carolina, 27708
About this study
Official title: Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management
The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. The investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with CKD. Specifically, the investigators will:
Aim 1: Modify an existing technology platform to build the iControl CKD system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate CKD.
Read more
Aim 2: Conduct qualitative interviews and user testing among patients with CKD to obtain feedback on the design of the intervention.
Aim 3: Conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the iControl CKD intervention.
- Conditions
- Chronic Kidney Diseases
- Being tested
- interactive Obesity Treatment Approach (iOTA)
- 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.
interactive Obesity Treatment Approach (iOTA)Behavioural
The investigators will adapt an evidence-based digital health intervention to promote adherence to nationally recommended diet and physical activity guidelines for patients with chronic kidney disease. The intervention includes goal assignment, goal tracking, and skills training messages.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interview | No intervention | Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report). |
| Pilot Testing | Other | Pilot Study: The investigators will enroll 30 adults at least 18 years old with mild to moderate CKD (documented estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2) who also have diabetes and/or hypertension. Receives: Behavioral: interactive Obesity Treatment Approach (iOTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts
Engagement with the intervention will be measured by calculating the proportion of participants responding to IVR calls or text tracking prompts over 1 month
Measured: Approximately 1 Month
Secondary outcomes (2)
Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus)
Analysis of 24-hour dietary recalls (1 weekday and 1 weekend day) at the beginning and end of the 1 month period
Measured: Approximately 1 Month
Change in physical activity minutes
Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention
Measured: Approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start13 May 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Why it stopped: Terminated due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dori Steinberg, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951363
- Sponsor's protocol ID
- Pro00101993
- Acronym
- iControl CKD
- Status last verified
- Feb 2021
- First submitted
- 14 May 2019
- Last updated
- 18 Feb 2021
- Results posted
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management
- ClinicalTrials.gov ID
- NCT03951363
- Acronym / sponsor ID
- iControl CKD / Pro00101993
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to COVID-19
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 15 May 2019 (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.
The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. The investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with CKD. Specifically, the investigators will:
Aim 1: Modify an existing technology platform to build the iControl CKD system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate CKD.
Aim 2: Conduct qualitative interviews and user testing among patients with CKD to obtain feedback on the design of the intervention.
Aim 3: Conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the iControl CKD intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interview | No intervention | –Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report). |
| Pilot Testing | Other | Behavioral: interactive Obesity Treatment Approach (iOTA)Pilot Study: The investigators will enroll 30 adults at least 18 years old with mild to moderate CKD (documented estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2) who also have diabetes and/or hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older
- Diagnosed with CKD (self-report)
- Proficient in English
- Age 18 or older
- Diagnosed with mild to moderate CKD (documented eGFR ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2 )
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| interactive Obesity Treatment Approach (iOTA)The investigators will adapt an evidence-based digital health intervention to promote adherence to nationally recommended diet and physical activity guidelines for patients with chronic kidney disease. The intervention includes goal assignment, goal tracking, and skills training messages. | Behavioural | Pilot Testing |
Primary outcome
Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts
Time frame: Approximately 1 Month
Engagement with the intervention will be measured by calculating the proportion of participants responding to IVR calls or text tracking prompts over 1 month
2 secondary outcomes
Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus)
Time frame: Approximately 1 Month
Change in physical activity minutes
Time frame: Approximately 1 month
Results and safety
The study was stopped early (reason given: Terminated due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Dori Steinberg, PhD, RD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive Obesity Treatment Approach (iOTA) in people with Chronic Kidney Diseases, run by Duke University at 1 site in United States.
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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Feb 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 United States. 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?
The study was stopped early (reason given: Terminated due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts (time frame: Approximately 1 Month). 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 18 Feb 2021.