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

Sponsor

AdventHealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05795036

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, we 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rehabilitation Physical Activity	Device: Mhealth	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Masking Description:

participants will be randomly assigned to either the intervention group or the control group

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 17, 2023

Anticipated Primary Completion Date :

Feb 17, 2024

Anticipated Study Completion Date :

Dec 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hope Clinic 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 Using a mHealth intervention to promote physical activity in Phase III cardiac rehabilitation clients

Arm

Intervention/Treatment

Experimental: Hope Clinic

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

Using a mHealth intervention to promote physical activity in Phase III cardiac rehabilitation clients

Outcome Measures

Primary Outcome Measures

Clients' demographic information will be obtained using a paper questionnaire administered at screening phase [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clients who met the following criteria will be recruited using convenience sampling: (i) currently receiving Phase III CR at Hope Clinic (ii) are 18 years of age or older (iii) can read and communicate in English (iv) able to follow instructions to walk (v) provided signed informed consent (vi) willing to wear Fitbit throughout the study (vii) 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) (viii) willing to receive text messages and phone calls from the research team.

Exclusion Criteria:

Clients will be excluded if they: (i) are pregnant or lactating (ii) have scheduled surgery or traveling within the next 8 weeks (iii) currently participating in other health promotion program (iv) 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").

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth University	Orlando	Florida	United States	32803

Sponsors and Collaborators

AdventHealth University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chia-Wei Fan, Investigator, AdventHealth University

ClinicalTrials.gov Identifier:

NCT05795036

Other Study ID Numbers:

1848850-2

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Apr 3, 2023