Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01404988
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2011-07-27
Brief Title:
Veterans Intensive Personalized Treatment in Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
VIP Veterans Intensive Personalized Treatment in Heart Failure
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
Brief Summary:
In the VIP Veterans Intensive Personalized Treatment in Heart Failure Study we will assess 2 novel interventions to enhance adherence and improve quality of life in veterans with heart failure This 3-arm randomized controlled trial will base one active arm on how ready patients are for change in terms of diet and medication adherence and will tailor the intervention based on this The other active arm will also assess how ready patients are for change but will also include tailoring based on availability of environment resources such as proximity to health food stores or social support to further tailor the intervention The last active arm is simply an attention group where patients will receive general health counseling in addition to background care that all patients receive The overarching hypothesis is that the tailored interventions will lower heart failure HF recurrence and improve quality of life by better medication and diet adherence compared to attention placebo
Detailed Description:
OBJECTIVES In the VIP Veterans Intensive Personalized Treatment in Heart Failure Study we will assess 2 novel interventions to enhance adherence and improve quality of life QOL in veterans with heart failure HF This theory-based pilot 3-arm randomized controlled trial RCT will base one active arm on the Transtheoretical Model TTM while the other active arm will add environmental built and human tailoring to TTM The overarching hypothesis driving this proposal is that a behavioral intervention BI which uses the TTM or a behavioral and environment-tailored intervention BEI will lower HF recurrence and improve QOL by better medication and diet adherence compared to attention control
RESEARCH DESIGN This is a practice-based RCT to test the effect of BI and BEI on medication and diet adherence The study is embedded in typical VA healthcare with all 3 arms incorporating the enhancements in HF care that have been implemented including the Patient Aligned Care Teams PACT system redesign methods to improve HF care ongoing HF quality improvement and Telehealth We will randomize 99 participants equally to BI BEI and AP All analyses will be intent to treat
METHODOLOGY The study sites will be the VAMCs at Manhattan and Brooklyn Participants will be veterans with classes I-III HF with prescribed HF medication for 6 months Men and women 21 years with history and clinical findings of chronic stable HF of NYHA functional class I previously symptomaticnow asymptomatic II or III are eligible They must have an available phone and 2 clinic visits in the previous 15 years Patients with poor short-term survival 1 year recent major surgery 3 months temporarily in the area or those unable to provide consent will be excluded After being screened for eligibility participants will come in for 2 study visits over the course of 6 months which will last about 15-2 hours At each visit a research assistant RA will administer a questionnaire assessing health behaviors including diet exercise and medication and quality of life The RAs will also measure height weight take 6 BP readings and send patients to the lab for blood and urine samples After the first clinic visit participants will be randomized to one of three telephone groups All participants will receive 1 phone call per month for 6 months which will last approximately 30-40 minutes 1 The BI group will receive TTM stage-matched counseling The interventionist will assess how ready patients are for change in terms of diet medication and exercise adherence and deliver a tailored intervention discussing adherence barriers 2 In the BEI in addition to using the TTM the intervention will tailor environmental factors such as availability of healthy food stores recreational facilities and support from caregivers in helping participants follow treatment recommendations We will speak with participants caregivers to educate them on heart failure as well The caregivers will receive a call every 2 months 3 in total lasting approximately 20-30 minutes 3 The control group will receive monthly telephone calls during which they will receive general health education Our primary analytic goal is to estimate the medication adherence rate and QOL to power a larger study We will also perform 1-sample Exact Binomial Tests comparing the active arms to the expected inactive control rate of 47 Since this is a pilot study we will use a 5 type 1 error rate 2-sided for each test All analyses will be intent to treat
RESEARCH DESIGN This is a practice-based RCT to test the effect of BI and BEI on medication and diet adherence The study is embedded in typical VA healthcare with all 3 arms incorporating the enhancements in HF care that have been implemented including the Patient Aligned Care Teams PACT system redesign methods to improve HF care ongoing HF quality improvement and Telehealth We will randomize 99 participants equally to BI BEI and AP All analyses will be intent to treat
METHODOLOGY The study sites will be the VAMCs at Manhattan and Brooklyn Participants will be veterans with classes I-III HF with prescribed HF medication for 6 months Men and women 21 years with history and clinical findings of chronic stable HF of NYHA functional class I previously symptomaticnow asymptomatic II or III are eligible They must have an available phone and 2 clinic visits in the previous 15 years Patients with poor short-term survival 1 year recent major surgery 3 months temporarily in the area or those unable to provide consent will be excluded After being screened for eligibility participants will come in for 2 study visits over the course of 6 months which will last about 15-2 hours At each visit a research assistant RA will administer a questionnaire assessing health behaviors including diet exercise and medication and quality of life The RAs will also measure height weight take 6 BP readings and send patients to the lab for blood and urine samples After the first clinic visit participants will be randomized to one of three telephone groups All participants will receive 1 phone call per month for 6 months which will last approximately 30-40 minutes 1 The BI group will receive TTM stage-matched counseling The interventionist will assess how ready patients are for change in terms of diet medication and exercise adherence and deliver a tailored intervention discussing adherence barriers 2 In the BEI in addition to using the TTM the intervention will tailor environmental factors such as availability of healthy food stores recreational facilities and support from caregivers in helping participants follow treatment recommendations We will speak with participants caregivers to educate them on heart failure as well The caregivers will receive a call every 2 months 3 in total lasting approximately 20-30 minutes 3 The control group will receive monthly telephone calls during which they will receive general health education Our primary analytic goal is to estimate the medication adherence rate and QOL to power a larger study We will also perform 1-sample Exact Binomial Tests comparing the active arms to the expected inactive control rate of 47 Since this is a pilot study we will use a 5 type 1 error rate 2-sided for each test All analyses will be intent to treat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None