DementiaNCT00178165
Coordinating Center for Enhancing ADRD Caregiving
A study testing Skill Training Condition - problem solving training and REACH for TLC (Telephone Linked Computer) system in people with Dementia and Alzheimer Disease, run by University of Pittsburgh at 5 sites in United States.
Trial summary
Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a unique, multi-site research program sponsored by the National Institute on Aging (NIA) and the National Institute on Nursing Research (NINR). 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?
- Skill Training Condition - problem solving training and REACH for TLC (Telephone Linked Computer) system
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 1996to Nov 2001
- 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
- NINCDS -ADRDA Criteria for Alzheimer's Disease and/or DSM IV Criteria for Alzheimer's Disease or other dementia or MMSE score < 23.
- Functional impairment: presence of two IADL or one ADL impairments.
- Age: 21 years and older
- Language: site specific, must be competent either orally or written
- Lives with care recipient
- Family member
Show all 11Show fewer
- Gender: Palo Alto/Los Angeles will only enroll women. All other sites will enroll men and women
- Must have a telephone
- At enrollment, plan to remain in area for the duration of the intervention and follow-up
- Caregiver role of at least 6 months
- Provides > 4 hours of supervision or direct assistance per day for the care recipient
Who cannot join
- Any terminal illness with life expectancy < 6 months
- Active treatment (chemotherapy, radiation therapy) for cancer
- More than three acute medical hospitalizations in past year (not for psychiatric or Alzheimer's Disease related admission)
- Schizophrenia (onset of delusions before age 45)
- Dementia secondary to head trauma (probable)
- Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
Show all 16Show fewer
- 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
- CORE CAREGIVER INCLUSION/EXCLUSION CRITERIA
- Any terminal illness with life expectancy < 6 months
- Active treatment (chemotherapy, radiation therapy) for cancer
- More than three acute medical hospitalizations in past year
- Involved in another clinical trial of interventions for caregivers (non drug study)
- Second Level Review If the caregiver has been inconsistent with answers or repeated answers, then the interviewer will administer the SPMSQ. The interviewer will then discuss with the PI and coordinate another phone call with the caregiver.
- If in the course of the telephone screen the research assistant believes that there may be difficulties for the caregiver regarding travel arrangements, hesitancy to answer questions, or other specific items (site-specific indications), the research assistant will refer to the PI for review.
- All potential caregivers will receive a follow-up phone call for second level exclusion from the trial when appropriate.
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 Enhancing Alzheimer Disease and Related Disorder Caregiving
Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a unique, multi-site research program sponsored by the National Institute on Aging (NIA) and the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature.
Read the detailed description
Six sites (Boston, Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) developed and evaluated a variety of multi-component interventions for family caregivers of persons with Alzheimer's Disease (AD) at the mild or moderate level of impairment. The multi-component interventions implemented across the six sites included: 1) Individual Information and Support strategies, 2) Group Support and Family Systems therapy, 3) Psychoeducational and Skill-based Training approaches, 4) Home-based Environmental interventions,, and 5) Enhanced Technology Support Systems. Although the interventions were derived from diverse theoretical models, they are all consistent with basic health-stress models in which the goal is to change the nature of specific stressors (e.g. problem behavior of the care recipient), their appraisal, and/or the caregivers response to the stressors. All of the REACH interventions were guided by detailed treatment manuals and certification procedures that assured that the interventions were delivered consistently over time at each site. Careful attention was also paid to the issue of treatment integrity. Different strategies were used at each site to induce and assess all three fundamental aspects of treatment integrity: delivery, receipt, and enactment (Burgio, et al., 2001). In addition, because the caregiving experience in race and ethnic minority families is particularly neglected in the field, there was a strong emphasis placed on the inclusion of African American and Hispanic caregivers. Thus, assessments as well as interventions were tailored at each site to meet the needs of culturally diverse racial/ethnic majority and minority populations.
All of the REACH sites shared several common goals, including: 1) designing theory-driven caregiving interventions to test hypotheses about intervention processes and their effect on family caregivers, 2) specifying intervention components that help us understand the pathways through which interventions produce desired outcomes, 3) developing a standardized outcome protocol to assess the impact of different strategies on caregivers and their care recipients within each site and across sites, and 4) creating a common database that would facilitate pooling data across sites. In addition, standard selection criteria were adopted by REACH.
Although REACH has some of the features of a traditional multi-site randomized controlled clinical trial (e.g., random assignment of participants to treatment and control conditions, common database and outcome measures, and identical measurement intervals across sites), it differs on one key dimension-the interventions varied across sites. REACH was designed to examine the feasibility and outcomes of multiple different intervention approaches, rather than to provide definitive information on the efficacy of one specific intervention strategy for enhancing caregiver outcomes. The strength of this approach is that it efficiently yields information about the effectiveness of different approaches to AD caregiving as well as the combined effects of active treatment versus controls, as reported in the planned meta-analysis.
REACH successfully randomized 1222 caregiver/care recipient dyads representing both majority and minority populations to 15 different conditions.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Skill Training Condition - problem solving training, REACH for TLC (Telephone Linked Computer) system
- 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.
Skill Training Condition - problem solving trainingProcedure or surgery
REACH for TLC (Telephone Linked Computer) systemProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcomes were assessed 6 months after randomization and included a measure of burden and a measure of depression. Caregiver burden was assessed using the Revised Memory and Behavior Problem Checklist (RMBPC).
Emotional distress was determined by the Center for Epidemiological Studies Depression Scale (CES-D) a global measure of depression.
Secondary outcomes (3)
Long-term care placement of dementia patients and caregiver health and well-being
Use of cognitive enhancement medication
Clinical significance of caregiver interventions in diverse populations
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 startSep 1996
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- None (open label)
- Enrolment
- 1,200 participants
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)
- 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
- NCT00178165
- Sponsor's protocol ID
- AG13305-01
- Other IDs
- NR13269, AG13313, AG13297, AG13289, AG13265, AG13255, AG13305
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Belle SH, Czaja SJ, Schulz R, Zhang S, Burgio LD, Gitlin LN, Jones R, Mendelsohn AB, Ory MG; REACH Investigators. Using a new taxonomy to combine the uncombinable: integrating results across diverse interventions. Psychol Aging. 2003 Sep;18(3):396-405. doi: 10.1037/0882-7974.18.3.396.
PubMed 14518803Czaja SJ, Schulz R, Lee CC, Belle SH; REACH Investigators. A methodology for describing and decomposing complex psychosocial and behavioral interventions. Psychol Aging. 2003 Sep;18(3):385-95. doi: 10.1037/0882-7974.18.3.385.
PubMed 14518802Wisniewski SR, Belle SH, Coon DW, Marcus SM, Ory MG, Burgio LD, Burns R, Schulz R; REACH Investigators. The Resources for Enhancing Alzheimer's Caregiver Health (REACH): project design and baseline characteristics. Psychol Aging. 2003 Sep;18(3):375-84. doi: 10.1037/0882-7974.18.3.375.
PubMed 14518801Gitlin LN, Belle SH, Burgio LD, Czaja SJ, Mahoney D, Gallagher-Thompson D, Burns R, Hauck WW, Zhang S, Schulz R, Ory MG; REACH Investigators. Effect of multicomponent interventions on caregiver burden and depression: the REACH multisite initiative at 6-month follow-up. Psychol Aging. 2003 Sep;18(3):361-74. doi: 10.1037/0882-7974.18.3.361.
PubMed 14518800Schulz R, Belle SH, Czaja SJ, Gitlin LN, Wisniewski SR, Ory MG; REACH Investigators. Introduction to the special section on Resources for Enhancing Alzheimer's Caregiver Health (REACH). Psychol Aging. 2003 Sep;18(3):357-60. doi: 10.1037/0882-7974.18.3.357.
PubMed 14518799Gallagher-Thompson D, Coon DW, Solano N, Ambler C, Rabinowitz Y, Thompson LW. Change in indices of distress among Latino and Anglo female caregivers of elderly relatives with dementia: site-specific results from the REACH national collaborative study. Gerontologist. 2003 Aug;43(4):580-91. doi: 10.1093/geront/43.4.580.
PubMed 12937336Burgio L, Stevens A, Guy D, Roth DL, Haley WE. Impact of two psychosocial interventions on white and African American family caregivers of individuals with dementia. Gerontologist. 2003 Aug;43(4):568-79. doi: 10.1093/geront/43.4.568.
PubMed 12937335Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67. doi: 10.1093/geront/43.4.556.
PubMed 12937334Burns R, Nichols LO, Martindale-Adams J, Graney MJ, Lummus A. Primary care interventions for dementia caregivers: 2-year outcomes from the REACH study. Gerontologist. 2003 Aug;43(4):547-55. doi: 10.1093/geront/43.4.547.
PubMed 12937333Gitlin LN, Winter L, Corcoran M, Dennis MP, Schinfeld S, Hauck WW. Effects of the home environmental skill-building program on the caregiver-care recipient dyad: 6-month outcomes from the Philadelphia REACH Initiative. Gerontologist. 2003 Aug;43(4):532-46. doi: 10.1093/geront/43.4.532.
PubMed 12937332Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Arguelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31. doi: 10.1093/geront/43.4.521.
PubMed 12937331Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003 Aug;43(4):514-20. doi: 10.1093/geront/43.4.514. No abstract available.
PubMed 12937330
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinating Center for Enhancing Alzheimer Disease and Related Disorder Caregiving
- ClinicalTrials.gov ID
- NCT00178165
- Acronym / sponsor ID
- AG13305-01
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
- Study start
- Sep 1996
- Study completion
- Nov 2001
- 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.
Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a unique, multi-site research program sponsored by the National Institute on Aging (NIA) and the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature.
Detailed description
Six sites (Boston, Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) developed and evaluated a variety of multi-component interventions for family caregivers of persons with Alzheimer's Disease (AD) at the mild or moderate level of impairment. The multi-component interventions implemented across the six sites included: 1) Individual Information and Support strategies, 2) Group Support and Family Systems therapy, 3) Psychoeducational and Skill-based Training approaches, 4) Home-based Environmental interventions,, and 5) Enhanced Technology Support Systems. Although the interventions were derived from diverse theoretical models, they are all consistent with basic health-stress models in which the goal is to change the nature of specific stressors (e.g. problem behavior of the care recipient), their appraisal, and/or the caregivers response to the stressors. All of the REACH interventions were guided by detailed treatment manuals and certification procedures that assured that the interventions were delivered consistently over time at each site. Careful attention was also paid to the issue of treatment integrity. Different strategies were used at each site to induce and assess all three fundamental aspects of treatment integrity: delivery, receipt, and enactment (Burgio, et al., 2001). In addition, because the caregiving experience in race and ethnic minority families is particularly neglected in the field, there was a strong emphasis placed on the inclusion of African American and Hispanic caregivers. Thus, assessments as well as interventions were tailored at each site to meet the needs of culturally diverse racial/ethnic majority and minority populations.
All of the REACH sites shared several common goals, including: 1) designing theory-driven caregiving interventions to test hypotheses about intervention processes and their effect on family caregivers, 2) specifying intervention components that help us understand the pathways through which interventions produce desired outcomes, 3) developing a standardized outcome protocol to assess the impact of different strategies on caregivers and their care recipients within each site and across sites, and 4) creating a common database that would facilitate pooling data across sites. In addition, standard selection criteria were adopted by REACH.
Although REACH has some of the features of a traditional multi-site randomized controlled clinical trial (e.g., random assignment of participants to treatment and control conditions, common database and outcome measures, and identical measurement intervals across sites), it differs on one key dimension-the interventions varied across sites. REACH was designed to examine the feasibility and outcomes of multiple different intervention approaches, rather than to provide definitive information on the efficacy of one specific intervention strategy for enhancing caregiver outcomes. The strength of this approach is that it efficiently yields information about the effectiveness of different approaches to AD caregiving as well as the combined effects of active treatment versus controls, as reported in the planned meta-analysis.
REACH successfully randomized 1222 caregiver/care recipient dyads representing both majority and minority populations to 15 different conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- NINCDS -ADRDA Criteria for Alzheimer's Disease and/or DSM IV Criteria for Alzheimer's Disease or other dementia or MMSE score < 23.
- Functional impairment: presence of two IADL or one ADL impairments.
- Age: 21 years and older
- Language: site specific, must be competent either orally or written
- Lives with care recipient
Key exclusion criteria (16 listed)
- Any terminal illness with life expectancy < 6 months
- Active treatment (chemotherapy, radiation therapy) for cancer
- More than three acute medical hospitalizations in past year (not for psychiatric or Alzheimer's Disease related admission)
- Schizophrenia (onset of delusions before age 45)
- Dementia secondary to head trauma (probable)
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 |
|---|---|---|
| Skill Training Condition - problem solving training | Procedure or surgery | – |
| REACH for TLC (Telephone Linked Computer) system | Procedure or surgery | – |
Primary outcome
The outcomes were assessed 6 months after randomization and included a measure of burden and a measure of depression. Caregiver burden was assessed using the Revised Memory and Behavior Problem Checklist (RMBPC).
Emotional distress was determined by the Center for Epidemiological Studies Depression Scale (CES-D) a global measure of depression.
3 secondary outcomes
Long-term care placement of dementia patients and caregiver health and well-being
Use of cognitive enhancement medication
Clinical significance of caregiver interventions in diverse populations
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 15 Sep 2005.
- Results publication: PubMed 14518803Belle SH, Czaja SJ, Schulz R, Zhang S, Burgio LD, Gitlin LN, Jones R, Mendelsohn AB, Ory MG; REACH Investigators. Using a new taxonomy to combine the uncombinable: integrating results across diverse interventions. Psychol Aging. 2003 Sep;18(3):396-405. doi: 10.1037/0882-7974.18.3.396.
- Results publication: PubMed 14518802Czaja SJ, Schulz R, Lee CC, Belle SH; REACH Investigators. A methodology for describing and decomposing complex psychosocial and behavioral interventions. Psychol Aging. 2003 Sep;18(3):385-95. doi: 10.1037/0882-7974.18.3.385.
- Results publication: PubMed 14518801Wisniewski SR, Belle SH, Coon DW, Marcus SM, Ory MG, Burgio LD, Burns R, Schulz R; REACH Investigators. The Resources for Enhancing Alzheimer's Caregiver Health (REACH): project design and baseline characteristics. Psychol Aging. 2003 Sep;18(3):375-84. doi: 10.1037/0882-7974.18.3.375.
- Results publication: PubMed 14518800Gitlin LN, Belle SH, Burgio LD, Czaja SJ, Mahoney D, Gallagher-Thompson D, Burns R, Hauck WW, Zhang S, Schulz R, Ory MG; REACH Investigators. Effect of multicomponent interventions on caregiver burden and depression: the REACH multisite initiative at 6-month follow-up. Psychol Aging. 2003 Sep;18(3):361-74. doi: 10.1037/0882-7974.18.3.361.
- Results publication: PubMed 14518799Schulz R, Belle SH, Czaja SJ, Gitlin LN, Wisniewski SR, Ory MG; REACH Investigators. Introduction to the special section on Resources for Enhancing Alzheimer's Caregiver Health (REACH). Psychol Aging. 2003 Sep;18(3):357-60. doi: 10.1037/0882-7974.18.3.357.
- Results publication: PubMed 12937336Gallagher-Thompson D, Coon DW, Solano N, Ambler C, Rabinowitz Y, Thompson LW. Change in indices of distress among Latino and Anglo female caregivers of elderly relatives with dementia: site-specific results from the REACH national collaborative study. Gerontologist. 2003 Aug;43(4):580-91. doi: 10.1093/geront/43.4.580.
- Results publication: PubMed 12937335Burgio L, Stevens A, Guy D, Roth DL, Haley WE. Impact of two psychosocial interventions on white and African American family caregivers of individuals with dementia. Gerontologist. 2003 Aug;43(4):568-79. doi: 10.1093/geront/43.4.568.
- Results publication: PubMed 12937334Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67. doi: 10.1093/geront/43.4.556.
- Results publication: PubMed 12937333Burns R, Nichols LO, Martindale-Adams J, Graney MJ, Lummus A. Primary care interventions for dementia caregivers: 2-year outcomes from the REACH study. Gerontologist. 2003 Aug;43(4):547-55. doi: 10.1093/geront/43.4.547.
- Results publication: PubMed 12937332Gitlin LN, Winter L, Corcoran M, Dennis MP, Schinfeld S, Hauck WW. Effects of the home environmental skill-building program on the caregiver-care recipient dyad: 6-month outcomes from the Philadelphia REACH Initiative. Gerontologist. 2003 Aug;43(4):532-46. doi: 10.1093/geront/43.4.532.
- Results publication: PubMed 12937331Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Arguelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31. doi: 10.1093/geront/43.4.521.
- Results publication: PubMed 12937330Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003 Aug;43(4):514-20. doi: 10.1093/geront/43.4.514. No abstract available.
- REACH I website- click here for more information about this studyLink provided by the sponsor.
Related trials for Dementia
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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 Skill Training Condition - problem solving training and REACH for TLC (Telephone Linked Computer) system 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 11 inclusion and 16 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 15 Sep 2005. 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?
The outcomes were assessed 6 months after randomization and included a measure of burden and a measure of depression. Caregiver burden was assessed using the Revised Memory and Behavior Problem Checklist (RMBPC).. The study lists 2 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 NCT00178165, which also lists 12 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 15 Sep 2005.