NCT02099513

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

March 26, 2014

Last Update Submit

February 21, 2017

Conditions

Keywords

Mobile TechnologyChronic illnessWireless blood pressure deviceWireless scalePedometer

Outcome Measures

Primary Outcomes (2)

  • Change in the Acceptance and use of technology survey

    Subject will take survey at Baseline, and the 1 month mark.

    Baseline, up to 1 Month

  • 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.

    1 month

Interventions

Also known as: mHealth

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • No internet/Wifi available in the home.
  • No Smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center, Pickens Primary Care Clinic

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

ObesityHypertensionDiabetes MellitusChronic Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic Processes

Study Officials

  • Ryan J. Shaw, RN, Phd

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 23, 2017

Record last verified: 2014-10

Locations