iControl Chronic Kidney Disease (iControl CKD)
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|ClinicalTrials.gov Identifier: NCT03951363|
Recruitment Status : Suspended (Suspended due to COVID-19 restrictions (funding and in-person visits))
First Posted : May 15, 2019
Last Update Posted : May 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Behavioral: interactive Obesity Treatment Approach (iOTA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management|
|Actual Study Start Date :||May 13, 2019|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2022|
No Intervention: Qualitative Interview
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.
Behavioral: 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.
- 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
- 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 ]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 [ Time Frame: Approximately 1 month ]Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951363
|United States, North Carolina|
|Duke Global Digital Health Science Center|
|Durham, North Carolina, United States, 27708|
|Principal Investigator:||Dori Steinberg, PhD, RD||Duke University|