iControl Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: interactive Obesity Treatment Approach (iOTA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Qualitative Interview<br>Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report). | |
| Other: Pilot Testing<br>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. | Behavioral: interactive Obesity Treatment Approach (iOTA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximately 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Approximately 1 month |