DementiaREACHNCT00177489
Coordinating Center for Caregiver Intervention Trial
A study testing multicomponent psychosocial intervention in people with Dementia and Alzheimer Disease, run by University of Pittsburgh at 5 sites in United States.
Trial summary
The primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer's disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer's Disease or… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- multicomponent psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2002to Sep 2005
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21 years or older
- Family member of the care recipient
- Must live with care recipient or share cooking facilities
- Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system
- Must plan to remain in the recruitment area for the duration of the intervention and follow-up
- Caregiver role for more than 6 months
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- Must provide on average 4 hours of supervision or direct assistance per day for the care recipient
- Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9
- NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)
Who cannot join
- Non-English, non-Spanish speaking
- Active treatment (chemotherapy, radiation therapy) for cancer
- Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
- Involvement in another clinical trial for caregivers
- Participant in REACH I study
- SPMSQ:> or = 4 errors*
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- If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study.
- Care Recipient Inclusion/Exclusion Criteria
- Non-English, non-Spanish speaking
- History of Parkinson's Disease or a stroke with no reported decline in memory over the past year
- Active treatment (chemotherapy, radiation therapy) for cancer
- More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission)
- Schizophrenia (onset of delusions before age 45) or other severe mental illness
- Dementia secondary to head trauma (probable)
- Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
- MMSE = 0 and Bedbound (confined to a bed or chair for >22 hours per day, for at least 4 of the past 7 days)
- Planned nursing home admission in 6 months
- Participant in REACH I study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2041
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Stanford University and Veterans Affairs
Menlo Park, California, 94025
University of Miami at Miami, Center on Adult Development and Aging
Miami, Florida, 33136
Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
Philadelphia, Pennsylvania, 19107
About this study
Official title: Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
The primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer's disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality of care of the care recipients, and 3) enhance the well-being of the caregivers.
Read the detailed description
The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer's Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition.
The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- multicomponent psychosocial intervention, Control arm
- Keywords
- Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies
- 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.
multicomponent psychosocial interventionBehavioural
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
Control armOther
Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months. Receives: Behavioral: multicomponent psychosocial intervention |
| Control | Other | Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention. Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Measured: six months
Secondary outcomes (1)
Caregiver clinical depression and patient institutional placement-six months post-randomization.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Richard Schulz, University of Pittsburgh
- Investigators
- Richard Schulz, Ph.D., Principal investigator, Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177489
- Sponsor's protocol ID
- AG13305
- Acronym
- REACH
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2005
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: There is no plan to make individual participant data available.
Publications
Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
PubMed 17116917Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Typical and atypical dementia family caregivers: systematic and objective comparisons. Int J Aging Hum Dev. 2011;72(1):27-43. doi: 10.2190/AG.72.1.b.
PubMed 21391405Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am Geriatr Soc. 2010 Jan;58(1):30-7. doi: 10.1111/j.1532-5415.2009.02631.x.
PubMed 20122038
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
- ClinicalTrials.gov ID
- NCT00177489
- Acronym / sponsor ID
- REACH / AG13305
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- Jun 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Sep 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 primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer's disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality of care of the care recipients, and 3) enhance the well-being of the caregivers.
Detailed description
The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer's Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition.
The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: multicomponent psychosocial interventionThe intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months. |
| Control | Other | Other: Control armCaregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)
Key exclusion criteria (18 listed)
- Non-English, non-Spanish speaking
- Active treatment (chemotherapy, radiation therapy) for cancer
- Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
- Involvement in another clinical trial for caregivers
- Participant in REACH I study
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 |
|---|---|---|
| multicomponent psychosocial interventionThe intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months. | Behavioural | Treatment |
| Control armCaregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention. | Other | Control |
Primary outcome
multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Time frame: six months
1 secondary outcome
Caregiver clinical depression and patient institutional placement-six months post-randomization.
Time frame: six months
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 Jan 2016.
- Results publication: PubMed 17116917Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
- Derived from this study: PubMed 21391405Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Typical and atypical dementia family caregivers: systematic and objective comparisons. Int J Aging Hum Dev. 2011;72(1):27-43. doi: 10.2190/AG.72.1.b.
- Derived from this study: PubMed 20122038Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am Geriatr Soc. 2010 Jan;58(1):30-7. doi: 10.1111/j.1532-5415.2009.02631.x.
- REACH II website- click here for more information about this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There is no plan to make individual participant data available.
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Stress
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.
Richard Schulz, Ph.D. principal investigator
Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multicomponent psychosocial intervention in people with Dementia and Alzheimer Disease, run by University of Pittsburgh at 5 sites 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 9 inclusion and 18 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization. (time frame: six months). 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 NCT00177489, which also lists 3 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 Jan 2016; AzTrials last refreshed its copy on 3 Nov 2026.