Using a mHealth Intervention to Promote Physical Activity... | NCT05795036

Studies
Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients

NCT05795036

Sponsor

AdventHealth University

Status

Recruiting

Last Update Posted

Jul 12, 2024Actual

Enrollment

46Estimated

Phase

Not Applicable

Conditions

Cardiac Rehabilitation
Physical Activity

Interventions

mHealth 1
mHealth 2

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2023Actual

Primary Completion Date

Aug 17, 2025Estimated

Completion Date

Dec 17, 2025Estimated

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2024

Last Update Posted Date

Jul 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Detailed Description

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hope Clinic	Experimental	Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.	Device: mHealth 1 Device: mHealth 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mHealth 1	Device	Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.	Hope Clinic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase	Descriptive statistics will be used to assess completeness of study data, normality of outcome measures, and potential covariates, and to identify potential covariate imbalances between study arms	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

currently receiving Phase III CR at Hope Clinic
are 18 years of age or older
can read and communicate in English
able to follow instructions to walk
provided signed informed consent
willing to wear Fitbit throughout the study
owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
willing to receive text messages and phone calls from the research team.

Exclusion Criteria:

are pregnant or lactating
have scheduled surgery or traveling within the next 8 weeks
currently participating in other health promotion program
sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chia-Wei Fan, MD	Contact	407-609-1388		chia-wei.fan@ahu.edu
Leana Goncalves Araujo, PhD	Contact	407-609-1388		leana.goncalvesaraujo@ahu.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AdventHealth University	Recruiting	Orlando	Florida	32803	United States