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The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frailty assessment
Quality of life assessment
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure focused on measuring frailty, advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Advanced heart failure patients.
  • These include patients with Current NYHA class III-IV symptoms at the current time or within the preceding three months.
  • Outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year OR patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (CCU)) and mention of cardiac rehab from service.

Exclusion criteria:

  • Unable to perform physical activities due to anatomic or musculoskeletal comorbidities
  • Physical activity is contraindicated

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Frailty assessment in Advanced heart failure

Arm Description

Subjects with advanced heart failure defined as current or recent (within the last 3 months) New York Heart Association (NYHA) class III or IV symptoms.

Outcomes

Primary Outcome Measures

Change in gait speed
The time it takes to walk a specified distance, as measured in meters per second
Change in hand grip
The amount of force that the hand can squeeze, as measured in kilograms
Change in Kansas City Cardiomyopathy Questionnaire
The KCCQ is a 23-item questionnaire that quantifies dyspnea, fatigue, and edema on physical, social, and emotional functions of the patient. Responses are categorized by 3 subscales (burden, limitations, and quality of life) with a possible range of scores from 0 to 100, 100 being the least burdened by their symptoms. This questionnaire independently measures the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life within a two week recall period.
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ asks each person to indicate using a 6-point (zero to five) Likert scale how much each of 21 facets prevents them from living as they desire. The questionnaire assesses the impact of frequent physical symptoms - shortness of breath, fatigue, peripheral edema, and difficulty sleeping - and psychological symptoms of anxiety and depression. In addition, the effects of heart failure on physical and social functioning are incorporated into the measure. Since treatments might have side effects in addition to ameliorating symptoms and functional limitations produced by heart failure, questions about side effects of medications, hospital stays and costs of care are also included to help measure the overall impact of a treatment on quality of life. Although the MLHFQ incorporates relevant aspects of the key dimensions of quality of life, the questionnaire was not designed to measure any particular dimension separately.

Secondary Outcome Measures

Delay in Left Ventricular Assist Device (LVAD) placement
Number of days until LVAD placement
Post surgical length of stay
Number of days subject in hospital

Full Information

First Posted
June 21, 2018
Last Updated
February 8, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03574662
Brief Title
The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
Official Title
A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Researchers are doing this study to find out if the cardiac rehabilitation program can improve measurements of frailty and improve independence, functional abilities, and feelings about health. Frailty can be measured by weakness (as measured by hand grip strength), slowness (as measured by walking speed), low level of physical activity, low energy or self-reported exhaustion, and unintentional weight loss.
Detailed Description
Participants with advanced heart failure with a New York Heart Association class of III or IV symptoms within the last 3 months will be identified by either their outpatient heart failure clinic notes or inpatient cardiology notes. Patients will be approached for participation if cardiac rehab is mentioned in the notes and inclusion/exclusion criteria it met. Once the consent is signed, the baseline visit will be scheduled, this will be done before cardiac rehab has started. The baseline visit include frailty assessment measured by a walk time/gait speed test and handgrip strength test, and quality of life assessment measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living with Heart Failure (MLHF) questionnaire. Patients will then attend cardiac rehabilitation for six week program. The cardiac rehab program will be designed by the individual facility due to the variation in exercise tolerance of each patient, no universal protocol will be used. After the six weeks of cardiac rehab, up to 16 weeks post-completion, the patient will return to Mayo Clinic Rochester to complete the frailty and quality of life assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
frailty, advanced

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Frailty assessment in Advanced heart failure
Arm Type
Experimental
Arm Description
Subjects with advanced heart failure defined as current or recent (within the last 3 months) New York Heart Association (NYHA) class III or IV symptoms.
Intervention Type
Other
Intervention Name(s)
Frailty assessment
Intervention Description
This assessment consists of a combination of gait speed measurement via infrared sensors as well as a grip strength assessment. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Intervention Type
Other
Intervention Name(s)
Quality of life assessment
Intervention Description
This assessment consists of two questionnaires, Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure questionnaire. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
Primary Outcome Measure Information:
Title
Change in gait speed
Description
The time it takes to walk a specified distance, as measured in meters per second
Time Frame
baseline, 6 weeks
Title
Change in hand grip
Description
The amount of force that the hand can squeeze, as measured in kilograms
Time Frame
baseline, 6 weeks
Title
Change in Kansas City Cardiomyopathy Questionnaire
Description
The KCCQ is a 23-item questionnaire that quantifies dyspnea, fatigue, and edema on physical, social, and emotional functions of the patient. Responses are categorized by 3 subscales (burden, limitations, and quality of life) with a possible range of scores from 0 to 100, 100 being the least burdened by their symptoms. This questionnaire independently measures the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life within a two week recall period.
Time Frame
baseline, 6 weeks
Title
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Description
The MLHFQ asks each person to indicate using a 6-point (zero to five) Likert scale how much each of 21 facets prevents them from living as they desire. The questionnaire assesses the impact of frequent physical symptoms - shortness of breath, fatigue, peripheral edema, and difficulty sleeping - and psychological symptoms of anxiety and depression. In addition, the effects of heart failure on physical and social functioning are incorporated into the measure. Since treatments might have side effects in addition to ameliorating symptoms and functional limitations produced by heart failure, questions about side effects of medications, hospital stays and costs of care are also included to help measure the overall impact of a treatment on quality of life. Although the MLHFQ incorporates relevant aspects of the key dimensions of quality of life, the questionnaire was not designed to measure any particular dimension separately.
Time Frame
baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Delay in Left Ventricular Assist Device (LVAD) placement
Description
Number of days until LVAD placement
Time Frame
16 weeks
Title
Post surgical length of stay
Description
Number of days subject in hospital
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Advanced heart failure patients. These include patients with Current NYHA class III-IV symptoms at the current time or within the preceding three months. Outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year OR patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (CCU)) and mention of cardiac rehab from service. Exclusion criteria: Unable to perform physical activities due to anatomic or musculoskeletal comorbidities Physical activity is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudhir S Kushwaha
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

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