iControl Chronic Kidney Disease (iControl CKD)

Duke University

Status: Terminated

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: interactive Obesity Treatment Approach (iOTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03951363

Pro00101993

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Qualitative Interview

No Intervention group

Description:

Interviews: The investigators will enroll at least 10 adults 18 years or older with CKD (self-report).

Pilot Testing

Other group

Description:

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.

Treatment:

Behavioral: interactive Obesity Treatment Approach (iOTA)