Cardiovascular DiseasesGET FITNCT03720327

The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults

A study testing Get FIT and Get FIT+ in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by University of California, Irvine at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Cardiovascular Diseases, Cardiovascular Risk Factor
What is being tested?: Get FIT and Get FIT+
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 5 sitesUnited States
Study dates: 10 Jan 2019to 12 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

aged 60 or greater
at intermediate (10-20%) or high risk (>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
reduced physical activity (as measured by Block Adult Physical Activity Screener)

Who cannot join

cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
chronic drug use
end stage renal, liver, or pulmonary disease
current active cancer (i.e., undergoing active treatment for cancer)
gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of California, Irvine Federally Qualified Health Clinic
Anaheim, California, 92801
The Regents of the University of California, Irvine - Institute for Clinical & Translational Science (ICTS)
Irvine, California, 92697-3959
University of California, Irvine Medical Clinic (Gottschalk)
Irvine, California, 92697
The University of California, Irvine Medical Center
Orange, California, 92697-3298
University of California, Irvine Federally Qualified Health Clinic
Santa Ana, California, 92701

Other trials in United States

About this study

Official title: Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.

Read the detailed description

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test 2 behavioral interventions in community-dwelling older adults (age ≥ 60 years) at intermediate and high risk of cardiovascular disease.

Get FIT: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach; vs.
Get FIT+: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach, and personalized push-only text messages from the health coach based on participant's progress as monitored electronically in the application.

Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.

Conditions: Cardiovascular Diseases, Cardiovascular Risk Factor
Being tested: Get FIT, Get FIT+
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Get FITBehavioural
The Get FIT arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; and one 45 minute behavioral counseling session to set personal goals and provide education by a health coach.
Get FIT+Behavioural
The Get FIT+ arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; one 45 minute behavioral counseling session to set personal goals and provide education by a health coach; and personalized text messaging for 3 months by a health coach. The health coach will have access to these participants' daily food and activity data through the smartphone application, and will monitor progress and send push-only text messages to participants in this group based on the participant's goals and progress in the areas of physical activity, nutrition, and weight loss.

Study groups in NCT03720327
Study group	Role	What they receive
Get FIT	Active comparator	The Get FIT intervention Receives: Behavioral: Get FIT
Get FIT+	Experimental	The Get FIT+ intervention, which includes push-only personalized text messages from a health coach. Receives: Behavioral: Get FIT+

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months
The Medical Outcomes Study Specific Adherence Scale measures patient adherence to 8 recommended health behaviors (3 items on specific diet/nutrition, 1 item on smoking cessation, 1 item on alcoholic beverages, 1 item on taking prescribed medications, 1 item on regular exercise, 1 item on weight/fluid, 1 item on symptom management). Participants circle the answer that best corresponds to their behavior in the last 4 weeks ("None of the time; 1-A little of the time; 2-Some of the time; 3-A good bit of the time; 4-Most of the time; 5-All of the time"). Scoring is the average of the items for a total specific adherence score.
Measured: baseline, 3 months, 6 months
Change from Baseline diet patterns at 3 months and 6 months
3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)
Measured: baseline, 3 months, 6 months
Change from baseline physical activity levels at 3 months and 6 months
data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)
Measured: baseline, 3 months, 6 months

Secondary outcomes (22)

change from baseline in HgA1c
HgA1c as obtained by venous puncture and blood analysis
Measured: baseline, 3 months, 6 months
Change from baseline in Anxiety and Depression symptoms
Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Subscale scores of Anxiety (range 0-21; lower scores representing "normal" scores) and Depression (range 0-21; lower scores representing "normal" scores).
Measured: baseline, 3 months, 6 months
Change from baseline in patient activation
Patient activation as measured by the Patient Activation Measure
Measured: baseline, 3 months, 6 months
Change from Baseline height in centimeters
height in centimeters as measured by stadiometer
Measured: baseline, 3 months, 6 months
Change from baseline weight in kilograms
weight in kilograms as measured by professional beam scale
Measured: baseline, 3 months, 6 months
Change from baseline body composition-area
body composition-area (cm2) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-Bone Mineral Content (BMC)
body composition - BMC (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-Bone Mineral Density (BMD)
body composition - BMD (g/cm2) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-Fat mass
body composition - fat mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-Lean mass
body composition - lean mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-Total Mass
body composition - total mass (g) as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline body composition-% fat
body composition - % fat as measured by dual-energy x-ray absorptiometry (DEXA)
Measured: baseline, 6 months
Change from baseline in blood pressure
blood pressure as measured by calibrated aneroid sphygmomanometer
Measured: baseline, 3 months, 6 months
Change from baseline in High-Density Lipoproteins (HDL)
HDL as obtained by venous puncture and blood analysis
Measured: baseline, 3 months, 6 months
Change from baseline in Low-Density Lipoproteins (LDL)
LDL as obtained by venous puncture and blood analysis
Measured: baseline, 3 months, 6 months
Change from baseline in Triglycerides
Triglycerides as obtained by venous puncture and blood analysis
Measured: baseline, 3 months, 6 months
Change from baseline in total cholesterol score
total cholesterol score as obtained by venous puncture and blood analysis (HDL+LDL+0.2*triglycerides=total)
Measured: baseline, 3 months, 6 months
change from baseline in quality of life
quality of life as measured by the Quality of Life Short Form version 20
Measured: baseline, 3 months, 6 months
change from baseline in patterns of use of clinic attendance
patient patterns of use as measured by clinic attendance
Measured: baseline, 3 months, 6 months
change from baseline in patterns of use of mHealth
patient patterns of use as measured by use of mHealth
Measured: baseline, 3 months, 6 months
change from baseline in patterns of use of Retention
patient patterns of use and engagement as measured by Retention (drop out rate and time of drop out)
Measured: baseline, 3 months, 6 months
cost effectiveness
Cost effectiveness of the intervention as calculated by the sum of costs of training, staff salary, frequency/duration of counseling sessions, follow up visits, real time feedback
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 201912 Mar 2022

First posted25 Oct 2018
Study start10 Jan 2019
Primary completion12 Mar 2022
Study completion12 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (56)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to one of two groups for the study duration (3 months): 1. control group (Get FIT); 2. intervention group (Get FIT+).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03720327
Sponsor's protocol ID: R21AG053162; HS#2016-2713
Other IDs: R21AG053162
Acronym: GET FIT
Status last verified: Nov 2022
First submitted: 9 Oct 2018
Last updated: 18 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Demiris G, Thompson H, Boquet J, Le T, Chaudhuri S, Chung J. Older adults' acceptance of a community-based telehealth wellness system. Inform Health Soc Care. 2013 Jan;38(1):27-36. doi: 10.3109/17538157.2011.647938. Epub 2012 May 9.
PubMed 22571733
Schneider KM, O'Donnell BE, Dean D. Prevalence of multiple chronic conditions in the United States' Medicare population. Health Qual Life Outcomes. 2009 Sep 8;7:82. doi: 10.1186/1477-7525-7-82.
PubMed 19737412
WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
PubMed 20019324
Lin JS, O'Connor E, Whitlock EP, Beil TL. Behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease in adults: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 7;153(11):736-50. doi: 10.7326/0003-4819-153-11-201012070-00007.
PubMed 21135297
Parekh AK, Goodman RA, Gordon C, Koh HK; HHS Interagency Workgroup on Multiple Chronic Conditions. Managing multiple chronic conditions: a strategic framework for improving health outcomes and quality of life. Public Health Rep. 2011 Jul-Aug;126(4):460-71. doi: 10.1177/003335491112600403.
PubMed 21800741
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
PubMed 12377092
Kouris I, Mougiakakou S, Scarnato L, Iliopoulou D, Diem P, Vazeou A, Koutsouris D. Mobile phone technologies and advanced data analysis towards the enhancement of diabetes self-management. Int J Electron Healthc. 2010;5(4):386-402. doi: 10.1504/IJEH.2010.036209.
PubMed 21041177
Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.
PubMed 21979293
Courtney KL, Demiris G, Rantz M, Skubic M. Needing smart home technologies: the perspectives of older adults in continuing care retirement communities. Inform Prim Care. 2008;16(3):195-201. doi: 10.14236/jhi.v16i3.694.
PubMed 19094406
Hayes DK, Denny CH, Keenan NL, Croft JB, Sundaram AA, Greenlund KJ. Racial/Ethnic and socioeconomic differences in multiple risk factors for heart disease and stroke in women: behavioral risk factor surveillance system, 2003. J Womens Health (Larchmt). 2006 Nov;15(9):1000-8. doi: 10.1089/jwh.2006.15.1000.
PubMed 17125418
Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, Giles WH, Capewell S. Explaining the decrease in U.S. deaths from coronary disease, 1980-2000. N Engl J Med. 2007 Jun 7;356(23):2388-98. doi: 10.1056/NEJMsa053935.
PubMed 17554120
Maruthur NM, Wang NY, Appel LJ. Lifestyle interventions reduce coronary heart disease risk: results from the PREMIER Trial. Circulation. 2009 Apr 21;119(15):2026-31. doi: 10.1161/CIRCULATIONAHA.108.809491. Epub 2009 Apr 6.
PubMed 19349322
Appel LJ, Brands MW, Daniels SR, Karanja N, Elmer PJ, Sacks FM; American Heart Association. Dietary approaches to prevent and treat hypertension: a scientific statement from the American Heart Association. Hypertension. 2006 Feb;47(2):296-308. doi: 10.1161/01.HYP.0000202568.01167.B6.
PubMed 16434724
Elmer PJ, Obarzanek E, Vollmer WM, Simons-Morton D, Stevens VJ, Young DR, Lin PH, Champagne C, Harsha DW, Svetkey LP, Ard J, Brantley PJ, Proschan MA, Erlinger TP, Appel LJ; PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. Ann Intern Med. 2006 Apr 4;144(7):485-95. doi: 10.7326/0003-4819-144-7-200604040-00007.
PubMed 16585662
Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

All Cardiovascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults
ClinicalTrials.gov ID: NCT03720327
Acronym / sponsor ID: GET FIT / R21AG053162; HS#2016-2713
Conditions: Cardiovascular Diseases, Cardiovascular Risk Factor
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Study start: 10 Jan 2019 (actual)
Primary completion: 12 Mar 2022 (actual)
Study completion: 12 Mar 2022 (actual)
First posted: 25 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Get FIT: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach; vs.
Get FIT+: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach, and personalized push-only text messages from the health coach based on participant's progress as monitored electronically in the application.

Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized to one of two groups for the study duration (3 months): 1. control group (Get FIT); 2. intervention group (Get FIT+).

Arm	Type	Receives
Get FIT	Active comparator	Behavioral: Get FITThe Get FIT intervention
Get FIT+	Experimental	Behavioral: Get FIT+The Get FIT+ intervention, which includes push-only personalized text messages from a health coach.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

aged 60 or greater
at intermediate (10-20%) or high risk (>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
reduced physical activity (as measured by Block Adult Physical Activity Screener)

Key exclusion criteria (5 listed)

cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
chronic drug use
end stage renal, liver, or pulmonary disease
current active cancer (i.e., undergoing active treatment for cancer)
gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Get FITThe Get FIT arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; and one 45 minute behavioral counseling session to set personal goals and provide education by a health coach.	Behavioural	Get FIT
Get FIT+The Get FIT+ arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; one 45 minute behavioral counseling session to set personal goals and provide education by a health coach; and personalized text messaging for 3 months by a health coach. The health coach will have access to these participants' daily food and activity data through the smartphone application, and will monitor progress and send push-only text messages to participants in this group based on the participant's goals and progress in the areas of physical activity, nutrition, and weight loss.	Behavioural	Get FIT+

Primary outcome

Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
The Medical Outcomes Study Specific Adherence Scale measures patient adherence to 8 recommended health behaviors (3 items on specific diet/nutrition, 1 item on smoking cessation, 1 item on alcoholic beverages, 1 item on taking prescribed medications, 1 item on regular exercise, 1 item on weight/fluid, 1 item on symptom management). Participants circle the answer that best corresponds to their behavior in the last 4 weeks ("None of the time; 1-A little of the time; 2-Some of the time; 3-A good bit of the time; 4-Most of the time; 5-All of the time"). Scoring is the average of the items for a total specific adherence score.
Change from Baseline diet patterns at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
3-Day Food Record (ASA24); data from self-recorded diet as entered in smartphone application (My Fitness Pal©)
Change from baseline physical activity levels at 3 months and 6 months
Time frame: baseline, 3 months, 6 months
data from Fitbit activity tracker as recorded in smartphone application (My Fitness Pal©)

22 secondary outcomes

change from baseline in HgA1c
Time frame: baseline, 3 months, 6 months
Change from baseline in Anxiety and Depression symptoms
Time frame: baseline, 3 months, 6 months
Change from baseline in patient activation
Time frame: baseline, 3 months, 6 months
Change from Baseline height in centimeters
Time frame: baseline, 3 months, 6 months
Change from baseline weight in kilograms
Time frame: baseline, 3 months, 6 months
Change from baseline body composition-area
Time frame: baseline, 6 months
Change from baseline body composition-Bone Mineral Content (BMC)
Time frame: baseline, 6 months
Change from baseline body composition-Bone Mineral Density (BMD)
Time frame: baseline, 6 months
Change from baseline body composition-Fat mass
Time frame: baseline, 6 months
Change from baseline body composition-Lean mass
Time frame: baseline, 6 months
Change from baseline body composition-Total Mass
Time frame: baseline, 6 months
Change from baseline body composition-% fat
Time frame: baseline, 6 months
Change from baseline in blood pressure
Time frame: baseline, 3 months, 6 months
Change from baseline in High-Density Lipoproteins (HDL)
Time frame: baseline, 3 months, 6 months
Change from baseline in Low-Density Lipoproteins (LDL)
Time frame: baseline, 3 months, 6 months
Change from baseline in Triglycerides
Time frame: baseline, 3 months, 6 months
Change from baseline in total cholesterol score
Time frame: baseline, 3 months, 6 months
change from baseline in quality of life
Time frame: baseline, 3 months, 6 months
change from baseline in patterns of use of clinic attendance
Time frame: baseline, 3 months, 6 months
change from baseline in patterns of use of mHealth
Time frame: baseline, 3 months, 6 months
change from baseline in patterns of use of Retention
Time frame: baseline, 3 months, 6 months
cost effectiveness
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
Background: PubMed 22571733Demiris G, Thompson H, Boquet J, Le T, Chaudhuri S, Chung J. Older adults' acceptance of a community-based telehealth wellness system. Inform Health Soc Care. 2013 Jan;38(1):27-36. doi: 10.3109/17538157.2011.647938. Epub 2012 May 9.
Background: PubMed 19737412Schneider KM, O'Donnell BE, Dean D. Prevalence of multiple chronic conditions in the United States' Medicare population. Health Qual Life Outcomes. 2009 Sep 8;7:82. doi: 10.1186/1477-7525-7-82.
Background: PubMed 20019324WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
Background: PubMed 21135297Lin JS, O'Connor E, Whitlock EP, Beil TL. Behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease in adults: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2010 Dec 7;153(11):736-50. doi: 10.7326/0003-4819-153-11-201012070-00007.
Background: PubMed 21800741Parekh AK, Goodman RA, Gordon C, Koh HK; HHS Interagency Workgroup on Multiple Chronic Conditions. Managing multiple chronic conditions: a strategic framework for improving health outcomes and quality of life. Public Health Rep. 2011 Jul-Aug;126(4):460-71. doi: 10.1177/003335491112600403.
Background: PubMed 12377092Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.
Background: PubMed 21041177Kouris I, Mougiakakou S, Scarnato L, Iliopoulou D, Diem P, Vazeou A, Koutsouris D. Mobile phone technologies and advanced data analysis towards the enhancement of diabetes self-management. Int J Electron Healthc. 2010;5(4):386-402. doi: 10.1504/IJEH.2010.036209.
Background: PubMed 21979293Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.
Background: PubMed 19094406Courtney KL, Demiris G, Rantz M, Skubic M. Needing smart home technologies: the perspectives of older adults in continuing care retirement communities. Inform Prim Care. 2008;16(3):195-201. doi: 10.14236/jhi.v16i3.694.
Background: PubMed 17125418Hayes DK, Denny CH, Keenan NL, Croft JB, Sundaram AA, Greenlund KJ. Racial/Ethnic and socioeconomic differences in multiple risk factors for heart disease and stroke in women: behavioral risk factor surveillance system, 2003. J Womens Health (Larchmt). 2006 Nov;15(9):1000-8. doi: 10.1089/jwh.2006.15.1000.
Background: PubMed 17554120Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, Giles WH, Capewell S. Explaining the decrease in U.S. deaths from coronary disease, 1980-2000. N Engl J Med. 2007 Jun 7;356(23):2388-98. doi: 10.1056/NEJMsa053935.
Background: PubMed 19349322Maruthur NM, Wang NY, Appel LJ. Lifestyle interventions reduce coronary heart disease risk: results from the PREMIER Trial. Circulation. 2009 Apr 21;119(15):2026-31. doi: 10.1161/CIRCULATIONAHA.108.809491. Epub 2009 Apr 6.
National Center for Chronic Disease Prevention and Health PromotionLink provided by the sponsor.
My Fitness PalLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Cardiovascular Diseases

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lorraine Evangelista, PhD principal investigator

University of California, Irvine

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Get FIT and Get FIT+ in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by University of California, Irvine at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline adherence to recommended self-care behaviors at 3 months and 6 months (time frame: baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03720327, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.