Clinical trial NCT02099513: The Mobile Health Platform
Official title: The Mobile Health Platform - Development and Feasibility Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Diabetes
Keywords: Mobile Technology
Chronic illness
Wireless blood pressure device
Wireless scale
Pedometer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Acceptance and use of technology survey
timeFrame: Baseline, up to 1 Month
measure: Perception of perceived usefulness, attitudes, and experiences
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Pickens Primary Care Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Ryan J. Shaw, RN, Phd
role: PRINCIPAL_INVESTIGATOR
References: