Caregiver BurdenPhase 1NCT00259415
Telesupport: Evaluation of Professionally Led Support Groups for Caregivers
A Phase 1 study testing Caregiver support via telephone in people with Caregiver Burden, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Caregiver support via telephone
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to not given
- Phase
- Phase 1
- 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 55 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.
Who cannot join
- Male
- under age of 55
- not a caregiver of person with ADRD
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluation of Professionally Led Support Groups for Caregivers
This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).
- Conditions
- Caregiver Burden
- Being tested
- Caregiver support via telephone
- Keywords
- Support groups, Alzheimer's Disease
- Medical subject headings
- Caregiver Burden, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver support via telephoneBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver depression
Caregiver burdern
Caregiver social support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Investigators
- Laura N Gitlin, Ph.D, Principal investigator, Thomas Jefferson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259415
- Sponsor's protocol ID
- IIRG-00-1998
- Status last verified
- Jul 2015
- First submitted
- 28 Nov 2005
- Last updated
- 8 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Professionally Led Support Groups for Caregivers
- ClinicalTrials.gov ID
- NCT00259415
- Acronym / sponsor ID
- IIRG-00-1998
- Conditions
- Caregiver Burden
- Keywords
- Support groups, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Sep 2000
- First posted
- 29 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.
This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.
Key exclusion criteria (3 listed)
- Male
- under age of 55
- not a caregiver of person with ADRD
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 |
|---|---|---|
| Caregiver support via telephone | Behavioural | – |
Primary outcome
Caregiver depression
Caregiver burdern
Caregiver social support
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 8 Jul 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caregiver support via telephone in people with Caregiver Burden, 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 1 inclusion and 3 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 8 Jul 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Caregiver depression. 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?
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 8 Jul 2015.