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Terminated due to COVID-19
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interactive Obesity Treatment Approach (iOTA) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Qualitative interview:
Inclusion criteria:
Pilot Groups:
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| Name | Affiliation | Role |
|---|---|---|
| Dori Steinberg, PhD, RD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Global Digital Health Science Center | Durham | North Carolina | 27708 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention |
| Approximately 1 month |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |