iControl Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— iControl CKD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03951363
• Other study ID #: Pro00101993
• Status: Terminated
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: February 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Global Digital Health Science Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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