iControl Chronic Kidney Disease (iControl CKD)
Primary Purpose
Chronic Kidney Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interactive Obesity Treatment Approach (iOTA)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion criteria:
Qualitative interview:
- Age 18 or older
- Diagnosed with CKD (self-report)
- Proficient in English
Inclusion criteria:
Pilot Groups:
- 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 )
- 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
Sites / Locations
- Duke Global Digital Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Qualitative Interview
Pilot Testing
Arm Description
Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report).
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change in physical activity minutes
Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03951363
Brief Title
iControl Chronic Kidney Disease
Acronym
iControl CKD
Official Title
Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to COVID-19
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qualitative Interview
Arm Type
No Intervention
Arm Description
Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report).
Arm Title
Pilot Testing
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
interactive Obesity Treatment Approach (iOTA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts
Description
Engagement with the intervention will be measured by calculating the proportion of participants responding to IVR calls or text tracking prompts over 1 month
Time Frame
Approximately 1 Month
Secondary Outcome Measure Information:
Title
Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus)
Description
Analysis of 24-hour dietary recalls (1 weekday and 1 weekend day) at the beginning and end of the 1 month period
Time Frame
Approximately 1 Month
Title
Change in physical activity minutes
Description
Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention
Time Frame
Approximately 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Qualitative interview:
Age 18 or older
Diagnosed with CKD (self-report)
Proficient in English
Inclusion criteria:
Pilot Groups:
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 )
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dori Steinberg, PhD, RD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Global Digital Health Science Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
iControl Chronic Kidney Disease
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