REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease (RESILIENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03978130|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Behavioral: Weekly Activities of Daily Living Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Behavioral: Weekly Activities of Daily Living
Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.
|Active Comparator: Usual Care||
Behavioral: Usual Care
Participants randomized to the usual care group will receive a tablet computer in order to complete the weekly ADL assessment.
- Change in the 6MWD between Baseline and 3 Month Follow Up [ Time Frame: 3 Months ]Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.
- Goal Attainment as measured by goal attainment scaling (GAS) [ Time Frame: 3 Months ]defined as whether a person's individual functional goals are achieved as a result of the study intervention, measured using a 5-point goal attainment scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978130
|Contact: Jenny Summapund||(646) 501-2646||Jenny.Summapund@nyulangone.org|
|United States, New York|
|NYU Langone Health||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Jenny Summapund, MA 646-501-2646 firstname.lastname@example.org|
|Principal Investigator: John Dodson, MD|
|Principal Investigator:||John Dodson, MD||New York Langone Health|