- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02099513
The Mobile Health Platform (mHealth)
The Mobile Health Platform - Development and Feasibility Evaluation
This study develops and pilots the initial interface of our mobile health platform that will allow for intra-individual tailoring and personalization of health interventions. This will allow for just-in-time interventions that adapt both the content and timing, not just initially, but also over time based upon prior outcome data, responses to an intervention, current environmental and social context, activity level, location, time, and an individual's psychophysiological state.1,2
Aim 1: To develop the initial interface of the mobile health platform that will allow patients to report and receive data representing multiple health domains including blood pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep, and self-report survey measures such as pain and fatigue.
Aim 2: To assess feasibility of the mobile health platform to receive and deliver data representing multiple health domains over 1 month through a single-case study design (N=6).3 Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate adaptive work by providing patients with automated real time feedback on their progress.
Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will facilitate adaptive approaches by alerting clinicians on the progress of their patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At baseline we will collect demographic variables and acceptance and use of technology from surveys, and biological variables including blood pressure, weight, and blood glucose from electronic medical records. Over a period of 1 month, participants will be asked to track and collect daily data on weight using the iHealth wireless scale. Participants will also collect blood pressure (BP), pO2, and pulse using the iHealth blood pressure device. Physical activity and sleep activity will be measured using the fitbit device. Participants will receive evidence-based daily nutrition and exercise weight loss messages via text messages.
Following the one-month observation participants will be asked to complete a follow-up survey on acceptance and use of technology and to undergo a post-formative semi-structure telephone interview to discuss their perception of the usefulness and attitudes toward the platform, technical difficulties and barriers, and recommendations for future development.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center, Pickens Primary Care Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient of Picket primary care clinic
- All subjects will provide written informed consent.
- Three participants who have multiple chronic illnesses.
- Chronic illnesses of obesity (BMI>29)
- Chronic hypertension (SBP>140)
- Three healthy participants who do not have any chronic illnesses.
- Own a smartphone with a data and text messaging plan.
- Have Wifi available in the home.
Exclusion Criteria:
- No internet/Wifi available in the home.
- No Smartphone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Acceptance and use of technology survey
Time Frame: Baseline, up to 1 Month
|
Subject will take survey at Baseline, and the 1 month mark.
|
Baseline, up to 1 Month
|
Perception of perceived usefulness, attitudes, and experiences
Time Frame: 1 month
|
Questions will be asked in the interviews regarding perceived usefulness, attitudes, and experiences of the mHealth applications.
The results will be divided into three main categories of positive, negative, and neutral perceptions.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan J. Shaw, RN, Phd, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00048816
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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