- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center, Pickens Primary Care Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the Acceptance and use of technology survey
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ryan J. Shaw, RN, Phd, Duke University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00048816
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