iControl Chronic Kidney Disease

Not Applicable

Terminated

• Conditions: Chronic Kidney Diseases
• Interventions: Behavioral: interactive Obesity Treatment Approach (iOTA)

• Registration Number: NCT03951363
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilot Testing	interactive Obesity Treatment Approach (iOTA)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Duke Global Digital Health Science Center; 🇺🇸 Durham, North Carolina, United States