NCT03951363

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

May 14, 2019

Last Update Submit

February 16, 2021

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in CKD diet adherence as measured through consumption of CKD-specific nutrients (i.e. sodium, protein, potassium, and phosphorus)

    Approximately 1 Month

  • Change in physical activity minutes

    Approximately 1 month

Study Arms (2)

Qualitative Interview

NO INTERVENTION

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

Pilot Testing

OTHER

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)

Interventions

interactive Obesity Treatment Approach (iOTA)BEHAVIORAL

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.

Pilot Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Qualitative interview:
  • Age 18 or older
  • Diagnosed with CKD (self-report)
  • Proficient in English
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Global Digital Health Science Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dori Steinberg, PhD, RD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 15, 2019

Study Start

May 13, 2019

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)