Frail ElderlyPhase 3NCT00249925
Project ABLE:Advancing Better Living for Elders
A Phase 3 study testing Home-Based Intervention and Multi-component home-based intervention in people with Frail Elderly, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention to improve home safety, fall efficacy and functional performance; 2) determine if the use of environmental strategies results in occurrence of less negative health events (falls and depression); 3) compare types of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Home-Based Intervention and Multi-component home-based intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jan 2005
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older
- community dwelling
- functional vulnerability/HRCA vulnerability index= >1 problem area
Who cannot join
- Mini-Mental Status Examination (MMSE) score of less than or equal to 23
- legal blindness
- bed bound
- nursing home placement or relocation expected within 12 months of study eligibility
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Corporation for Aging (PCA)
Philadelphia, Pennsylvania, 19130
About this study
Official title: Enhancing Function of Frail Elders At Home
The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention to improve home safety, fall efficacy and functional performance; 2) determine if the use of environmental strategies results in occurrence of less negative health events (falls and depression); 3) compare types of environmental strategies accepted and used under different treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.
- Conditions
- Frail Elderly
- Being tested
- Home-Based Intervention, Multi-component home-based intervention
- Keywords
- Home modification, Occupational Therapy, Physical Therapy, Home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based InterventionBehavioural
Multi-component home-based interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional difficulty
Fear of falling
Self-efficacy
Secondary outcomes (3)
Home hazards
Control oriented strategy use
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startJan 2000
- Primary completionJun 2004
- Study completionJan 2005
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 Frail ElderlyStudies 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 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 319 participants
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura N Gitlin, Ph.D, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249925
- Sponsor's protocol ID
- R01AG013687
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2005
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rose KC, Gitlin LN, Dennis MP. Readiness to use compensatory strategies among older adults with functional difficulties. Int Psychogeriatr. 2010 Dec;22(8):1225-39. doi: 10.1017/S1041610210001584. Epub 2010 Jul 27.
PubMed 20663239
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Function of Frail Elders At Home
- ClinicalTrials.gov ID
- NCT00249925
- Acronym / sponsor ID
- R01AG013687
- Conditions
- Frail Elderly
- Keywords
- Home modification, Occupational Therapy, Physical Therapy, Home care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 7 Nov 2005 (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 specific aims of the study are to: 1) test the effectiveness of a home-bases intervention to improve home safety, fall efficacy and functional performance; 2) determine if the use of environmental strategies results in occurrence of less negative health events (falls and depression); 3) compare types of environmental strategies accepted and used under different treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70 years or older
- community dwelling
- functional vulnerability/HRCA vulnerability index= >1 problem area
Key exclusion criteria (4 listed)
- Mini-Mental Status Examination (MMSE) score of less than or equal to 23
- legal blindness
- bed bound
- nursing home placement or relocation expected within 12 months of study eligibility
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 |
|---|---|---|
| Home-Based Intervention | Behavioural | – |
| Multi-component home-based intervention | Behavioural | – |
Primary outcome
Functional difficulty
Fear of falling
Self-efficacy
3 secondary outcomes
Home hazards
Control oriented strategy use
Mortality
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 26 Apr 2016.
- Derived from this study: PubMed 20663239Rose KC, Gitlin LN, Dennis MP. Readiness to use compensatory strategies among older adults with functional difficulties. Int Psychogeriatr. 2010 Dec;22(8):1225-39. doi: 10.1017/S1041610210001584. Epub 2010 Jul 27.
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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.
Laura N Gitlin, Ph.D principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home-Based Intervention and Multi-component home-based intervention in people with Frail Elderly, run by Thomas Jefferson University at 1 site 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 3 inclusion and 4 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional difficulty. 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 NCT00249925, 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 26 Apr 2016.