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The Mobile Health Platform (mHealth)

Primary Purpose

Obesity, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Mobile Health Platform
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obesity focused on measuring Mobile Technology, Chronic illness, Wireless blood pressure device, Wireless scale, Pedometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University Medical Center, Pickens Primary Care Clinic

Outcomes

Primary Outcome Measures

Change in the Acceptance and use of technology survey
Subject will take survey at Baseline, and the 1 month mark.
Perception of perceived usefulness, attitudes, and experiences
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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2014
Last Updated
February 21, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02099513
Brief Title
The Mobile Health Platform
Acronym
mHealth
Official Title
The Mobile Health Platform - Development and Feasibility Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension, Diabetes
Keywords
Mobile Technology, Chronic illness, Wireless blood pressure device, Wireless scale, Pedometer

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
The Mobile Health Platform
Other Intervention Name(s)
mHealth
Primary Outcome Measure Information:
Title
Change in the Acceptance and use of technology survey
Description
Subject will take survey at Baseline, and the 1 month mark.
Time Frame
Baseline, up to 1 Month
Title
Perception of perceived usefulness, attitudes, and experiences
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan J. Shaw, RN, Phd
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center, Pickens Primary Care Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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The Mobile Health Platform

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