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OpenTrials
Completed

NCT Number: NCT02099513

The Mobile Health Platform

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Pickens Primary Care Clinic

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Mobile Health Platform

Device

Other names: mHealth

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Mobile Health Platform - Development and Feasibility Evaluation

Acronym: mHealth

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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