Chronic Kidney Diseases
Conditions
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.
Interventions
BEHAVIORALinteractive 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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus) | 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 | Approximately 1 month | Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention |
Countries
United States
Outcome results
None listed