DementiaPhase 2NCT00735800
Telephone Support for Dementia Caregivers
A Phase 2 study testing Family Intervention:Telephone Tracking Support- Caregiver and Telephone Support in people with Dementia, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Dementia
- What is being tested?
- Family Intervention:Telephone Tracking Support- Caregiver and Telephone Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2013
- Phase
- Phase 2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Diagnosis of dementia;
- 2) mild to moderate dementia;
- 3) family member or other adult in caregiver role for at least 6 months, and who provides at least 4 hours of supervision or direct assistance per day for the person with dementia;
- 4) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
- 5) there is no plan for the care recipient to be placed in long term care or the caregiver to end their role within the next 6 months
Who cannot join
- Patient:
- 1) other major medical condition affecting independent functioning
- 2) older than age 90; and
- 3) younger than age 50.
- Caregiver:
- 1) major acute medical illness;
Show all 10Show fewer
- 2) English not primary language;
- 3) cognitive impairment;
- 4) no access to a telephone; or
- 5) older than age 90.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02905
About this study
Official title: Psychosocial Telephone Intervention for Dementia Caregivers
Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress.
Read the detailed description
A previous pilot study of this approach showed reduced burden and reaction to memory and behavior problems for dementia caregivers. This study will test the intervention in a larger group of caregivers and have a more detailed analysis of outcomes.
The caregiver of a person with dementia will receive telephone support calls. They will receive telephone calls from a trained member of the research team. These calls will occur over a six-month period and will be scheduled at a time that is convenient for the caregiver. They will receive a total of 16 calls over 6 months. During each call, the support person will discuss their current caregiving situation and provide various forms of support.
- Conditions
- Dementia
- Being tested
- Family Intervention:Telephone Tracking Support- Caregiver, Telephone Support
- Keywords
- Dementia, Caregivers, Alzheimer's disease
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Intervention:Telephone Tracking Support- CaregiverBehavioural
Also called FITT-C
Family-based problem solving treatment
Telephone SupportBehavioural
Supportive telephone counseling about caregiving
| Study group | Role | What they receive |
|---|---|---|
| Supportive Counseling | Active comparator | Not described Receives: Behavioral: Telephone Support |
| Problem-Solving | Experimental | Not described Receives: Behavioral: Family Intervention:Telephone Tracking Support- Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, burden, reaction to memory and behavior problems
Measured: Every two months, over a 6 month time-period , and a three month follow-up
Secondary outcomes (1)
Cost-effectiveness and resource use
Measured: Monthly resource check-ins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Geoffrey Tremont, Rhode Island Hospital
- Investigators
- Geoffery Tremont, Ph.D, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735800
- Sponsor's protocol ID
- R01NR010559
- Other IDs
- R01NR010559
- Status last verified
- May 2015
- First submitted
- 14 Aug 2008
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruce JM, McQuiggan M, Williams V, Westervelt H, Tremont G. Burden among spousal and child caregivers of patients with mild cognitive impairment. Dement Geriatr Cogn Disord. 2008;25(4):385-90. doi: 10.1159/000122587. Epub 2008 Mar 29.
PubMed 18376128Davis JD, Tremont G. Impact of frontal systems behavioral functioning in dementia on caregiver burden. J Neuropsychiatry Clin Neurosci. 2007 Winter;19(1):43-9. doi: 10.1176/jnp.2007.19.1.43.
PubMed 17308226Epstein-Lubow G, Davis JD, Miller IW, Tremont G. Persisting burden predicts depressive symptoms in dementia caregivers. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):198-203. doi: 10.1177/0891988708320972.
PubMed 18838742Spitznagel MB, Tremont G, Davis JD, Foster SM. Psychosocial predictors of dementia caregiver desire to institutionalize: caregiver, care recipient, and family relationship factors. J Geriatr Psychiatry Neurol. 2006 Mar;19(1):16-20. doi: 10.1177/0891988705284713.
PubMed 16449755Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.
PubMed 17548782Tremont G, Davis JD, Bishop DS. Unique contribution of family functioning in caregivers of patients with mild to moderate dementia. Dement Geriatr Cogn Disord. 2006;21(3):170-4. doi: 10.1159/000090699. Epub 2006 Jan 3.
PubMed 16397397Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.
PubMed 20228893
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Telephone Intervention for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT00735800
- Acronym / sponsor ID
- R01NR010559
- Conditions
- Dementia
- Keywords
- Dementia, Caregivers, Alzheimer's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Aug 2008 (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.
Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress.
Detailed description
A previous pilot study of this approach showed reduced burden and reaction to memory and behavior problems for dementia caregivers. This study will test the intervention in a larger group of caregivers and have a more detailed analysis of outcomes.
The caregiver of a person with dementia will receive telephone support calls. They will receive telephone calls from a trained member of the research team. These calls will occur over a six-month period and will be scheduled at a time that is convenient for the caregiver. They will receive a total of 16 calls over 6 months. During each call, the support person will discuss their current caregiving situation and provide various forms of support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Counseling | Active comparator | Behavioral: Telephone Support |
| Problem-Solving | Experimental | Behavioral: Family Intervention:Telephone Tracking Support- Caregiver |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Diagnosis of dementia;
- 2) mild to moderate dementia;
- 3) family member or other adult in caregiver role for at least 6 months, and who provides at least 4 hours of supervision or direct assistance per day for the person with dementia;
- 4) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
- 5) there is no plan for the care recipient to be placed in long term care or the caregiver to end their role within the next 6 months
Key exclusion criteria (10 listed)
- 1) other major medical condition affecting independent functioning
- 2) older than age 90; and
- 3) younger than age 50.
- 1) major acute medical illness;
- 2) English not primary language;
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 |
|---|---|---|
| Family Intervention:Telephone Tracking Support- CaregiverAlso: FITT-CFamily-based problem solving treatment | Behavioural | Problem-Solving |
| Telephone SupportSupportive telephone counseling about caregiving | Behavioural | Supportive Counseling |
Primary outcome
Depression, burden, reaction to memory and behavior problems
Time frame: Every two months, over a 6 month time-period , and a three month follow-up
1 secondary outcome
Cost-effectiveness and resource use
Time frame: Monthly resource check-ins.
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 5 May 2015.
- Background: PubMed 18376128Bruce JM, McQuiggan M, Williams V, Westervelt H, Tremont G. Burden among spousal and child caregivers of patients with mild cognitive impairment. Dement Geriatr Cogn Disord. 2008;25(4):385-90. doi: 10.1159/000122587. Epub 2008 Mar 29.
- Background: PubMed 17308226Davis JD, Tremont G. Impact of frontal systems behavioral functioning in dementia on caregiver burden. J Neuropsychiatry Clin Neurosci. 2007 Winter;19(1):43-9. doi: 10.1176/jnp.2007.19.1.43.
- Background: PubMed 18838742Epstein-Lubow G, Davis JD, Miller IW, Tremont G. Persisting burden predicts depressive symptoms in dementia caregivers. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):198-203. doi: 10.1177/0891988708320972.
- Background: PubMed 16449755Spitznagel MB, Tremont G, Davis JD, Foster SM. Psychosocial predictors of dementia caregiver desire to institutionalize: caregiver, care recipient, and family relationship factors. J Geriatr Psychiatry Neurol. 2006 Mar;19(1):16-20. doi: 10.1177/0891988705284713.
- Background: PubMed 17548782Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.
- Background: PubMed 16397397Tremont G, Davis JD, Bishop DS. Unique contribution of family functioning in caregivers of patients with mild to moderate dementia. Dement Geriatr Cogn Disord. 2006;21(3):170-4. doi: 10.1159/000090699. Epub 2006 Jan 3.
- Background: PubMed 20228893Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.
- Link to study webpageLink provided by the sponsor.
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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.
Geoffery Tremont, Ph.D principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Family Intervention:Telephone Tracking Support- Caregiver and Telephone Support in people with Dementia, run by Rhode Island Hospital 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 5 inclusion and 10 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 5 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Depression, burden, reaction to memory and behavior problems (time frame: Every two months, over a 6 month time-period , and a three month follow-up). 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 NCT00735800, which also lists 7 linked publications.
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 5 May 2015.