Heart Failure, CongestiveNCT00328848
After Discharge Management of Low Income Frail Elderly
A study testing Behavioral in people with Heart Failure, Congestive and Coronary Arteriosclerosis, run by Summa Health System.
Trial summary
The purpose of this study is to determine whether comprehensive post-hospitalization interdisciplinary care management can be an effective care delivery model to improve outcomes in low-income frail elderly. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Heart Failure, Congestive, Coronary Arteriosclerosis, Atrial Fibrillation
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Apr 2013
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 65 years old
- Confirmed or probable dual eligible
- Have at least one chronic illness (chronic obstructive pulmonary disease [COPD], diabetes, stroke/atrial fibrillation, ischemic heart disease, hypertension, congestive heart failure [CHF], osteoporosis, osteoarthritis) and at least 1 impaired activity of daily living (ADL) 11 or 2 impaired instrumental activities of daily living (IADLs)
- Be discharged home or to a skilled nursing facility (or acute rehabilitation) for a maximum of 8 weeks before being discharged to home
Who cannot join
- Enrolled in this health system's care management program
- Chemically dependent
- Those with a Mental Status Questionnaire score > 5
- Diagnosed psychosis
- Dialysis
- Terminal diagnosis/hospice
About this study
Official title: After Discharge Management of Low Income Frail Elderly (AD-LIFE)
The purpose of this study is to determine whether comprehensive post-hospitalization interdisciplinary care management can be an effective care delivery model to improve outcomes in low-income frail elderly.
Read the detailed description
This randomized trial will test the effectiveness of improved clinical practice through comprehensive care management in elderly patients with chronic illness and functional impairment discharged from an acute care hospital. For the intervention group, patient care will be coordinated by a nurse care manager who will perform a comprehensive in home assessment and provide patient education and self management support. The care manager will work with an interdisciplinary team (IT) to develop and implement a plan of care. Evidence based care plans will be implemented in collaboration with the patient, the primary care physician (PCP), the local Area Agency on Aging (AAoA), and other community social agencies. The care manager will provide frequent patient follow up across all providers to ensure integration of medical and social issues. Control patients will be referred to the local AAoA with no IT follow up. Although control patients will receive, through the AAoA, referrals for care and psychosocial support, the absence of a care manager and IT will, we expect, result in functional decline, lower quality of life, and higher health care costs.
The intervention (n=265) and control (n=265) groups will be compared at 1 year on a profile of health and well being using a multiple endpoint global hypothesis testing strategy. The global measure will be comprised of the following 5 domains: function, institutionalization, quality of life, quality of medical management, and quality of self management. Priority populations identified by AHRQ who are targeted in this study include the elderly, patients with chronic illnesses, low income (dual eligible), and patients with disabilities. This study also includes minorities, women, and patients who live in the inner city. Future economic analyses of benefits (for which alternative funding is currently being sought) will inform policy makers about funding care management in AHRQ priority populations.
- Conditions
- Heart Failure, Congestive, Coronary Arteriosclerosis, Atrial Fibrillation, Cerebrovascular Accident, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
- Being tested
- Behavioral
- Keywords
- patient care management, chronic disease
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Atrial Fibrillation, Stroke, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Hypertension, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
Group Treatment(patient education, self management support, caregiver support)
behavioralBehavioural
patient education, self management support, caregiver support
| Study group | Role | What they receive |
|---|---|---|
| Intervention care management | Experimental | post dischsrge care management by a nurse care manager who performs in-home vistis and reports to a interdisciplinary team. Team generates care recommendations based on patient goals. PCP and care manager implement the care plan that is based on patient goals. Includes education, behavioral interventions, and coaching. Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Measured: Length of Study
Quality of life
Measured: Duration
Quality of medical management
Measured: Duration
Secondary outcomes (2)
Mortality
Measured: Duration
Opportunity costs of caregiver time
Measured: Duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startOct 2005
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan E. Hazelett, Summa Health System
- Investigators
- Kyle R Allen, DO, Principal investigator, Riverside Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328848
- Sponsor's protocol ID
- 1R01HS014539-01A1
- Other IDs
- 1R01HS014539-01A1
- Status last verified
- Jul 2014
- First submitted
- 18 May 2006
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allen KR, Hazelett SE, Jarjoura D, Wright K, Fosnight SM, Kropp DJ, Hua K, Pfister EW. The after discharge care management of low income frail elderly (AD-LIFE) randomized trial: theoretical framework and study design. Popul Health Manag. 2011 Jun;14(3):137-42. doi: 10.1089/pop.2010.0016. Epub 2011 Feb 15.
PubMed 21323461
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Discharge Management of Low Income Frail Elderly (AD-LIFE)
- ClinicalTrials.gov ID
- NCT00328848
- Acronym / sponsor ID
- 1R01HS014539-01A1
- Conditions
- Heart Failure, Congestive, Coronary Arteriosclerosis, Atrial Fibrillation, Cerebrovascular Accident, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
- Keywords
- patient care management, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 May 2006 (estimated)
- 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.
The purpose of this study is to determine whether comprehensive post-hospitalization interdisciplinary care management can be an effective care delivery model to improve outcomes in low-income frail elderly.
Detailed description
This randomized trial will test the effectiveness of improved clinical practice through comprehensive care management in elderly patients with chronic illness and functional impairment discharged from an acute care hospital. For the intervention group, patient care will be coordinated by a nurse care manager who will perform a comprehensive in home assessment and provide patient education and self management support. The care manager will work with an interdisciplinary team (IT) to develop and implement a plan of care. Evidence based care plans will be implemented in collaboration with the patient, the primary care physician (PCP), the local Area Agency on Aging (AAoA), and other community social agencies. The care manager will provide frequent patient follow up across all providers to ensure integration of medical and social issues. Control patients will be referred to the local AAoA with no IT follow up. Although control patients will receive, through the AAoA, referrals for care and psychosocial support, the absence of a care manager and IT will, we expect, result in functional decline, lower quality of life, and higher health care costs.
The intervention (n=265) and control (n=265) groups will be compared at 1 year on a profile of health and well being using a multiple endpoint global hypothesis testing strategy. The global measure will be comprised of the following 5 domains: function, institutionalization, quality of life, quality of medical management, and quality of self management. Priority populations identified by AHRQ who are targeted in this study include the elderly, patients with chronic illnesses, low income (dual eligible), and patients with disabilities. This study also includes minorities, women, and patients who live in the inner city. Future economic analyses of benefits (for which alternative funding is currently being sought) will inform policy makers about funding care management in AHRQ priority populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention care management | Experimental | Behavioral: Behavioralpost dischsrge care management by a nurse care manager who performs in-home vistis and reports to a interdisciplinary team. Team generates care recommendations based on patient goals. PCP and care manager implement the care plan that is based on patient goals. Includes education, behavioral interventions, and coaching. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- > 65 years old
- Confirmed or probable dual eligible
- Have at least one chronic illness (chronic obstructive pulmonary disease [COPD], diabetes, stroke/atrial fibrillation, ischemic heart disease, hypertension, congestive heart failure [CHF], osteoporosis, osteoarthritis) and at least 1 impaired activity of daily living (ADL) 11 or 2 impaired instrumental activities of daily living (IADLs)
- Be discharged home or to a skilled nursing facility (or acute rehabilitation) for a maximum of 8 weeks before being discharged to home
Key exclusion criteria (6 listed)
- Enrolled in this health system's care management program
- Chemically dependent
- Those with a Mental Status Questionnaire score > 5
- Diagnosed psychosis
- Dialysis
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 |
|---|---|---|
| BehavioralGroup Treatment(patient education, self management support, caregiver support) | Behavioural | Intervention care management |
| behavioralpatient education, self management support, caregiver support | Behavioural | Intervention care management |
Primary outcome
Function
Time frame: Length of Study
Quality of life
Time frame: Duration
Quality of medical management
Time frame: Duration
2 secondary outcomes
Mortality
Time frame: Duration
Opportunity costs of caregiver time
Time frame: Duration
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 17 Jul 2014.
- Background: PubMed 21323461Allen KR, Hazelett SE, Jarjoura D, Wright K, Fosnight SM, Kropp DJ, Hua K, Pfister EW. The after discharge care management of low income frail elderly (AD-LIFE) randomized trial: theoretical framework and study design. Popul Health Manag. 2011 Jun;14(3):137-42. doi: 10.1089/pop.2010.0016. Epub 2011 Feb 15.
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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.
Kyle R Allen, DO principal investigator
Riverside Health System
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Heart Failure, Congestive and Coronary Arteriosclerosis, run by Summa Health System.
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 6 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Function (time frame: Length of Study). 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 NCT00328848, which also lists 1 linked publication.
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 17 Jul 2014.