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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03951363
Other study ID # Pro00101993
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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