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iControl Chronic Kidney Disease (iControl CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951363
Recruitment Status : Terminated (Terminated due to COVID-19)
First Posted : May 15, 2019
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Behavioral: interactive Obesity Treatment Approach (iOTA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Digital Health to Improve Diet and Exercise Adherence for Chronic Kidney Disease Management
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : February 20, 2020
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Qualitative Interview
Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report).
Pilot Testing
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants responding to Interactive Voice Response (IVR) calls or text tracking prompts [ Time Frame: 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 :
  1. Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus) [ Time Frame: 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

  2. Change in physical activity minutes [ Time Frame: Approximately 1 month ]
    Self-reported physical activity will be measured via the Paffenbarger Exercise Habits Questionnaire pre- and post intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951363


Locations
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United States, North Carolina
Duke Global Digital Health Science Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Dori Steinberg, PhD, RD Duke University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03951363    
Other Study ID Numbers: Pro00101993
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency