- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378195
iCare Stress Management e-Training for Dementia Family Caregivers (iCare)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to develop the iCare Program, a DVD/online video training that builds skills and stimulates practice. We are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. We are designing the program to help to enhance caregivers' skills to deal with demanding tasks of caregiving, alleviate related stress, and improve quality of life.
Research Program Steps:
- Caregivers will be asked some simple questions about themselves and their family members to see if they are eligible for the project (fill out Enrollment Form and Informed Consent).
- A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.
- A DVD, materials, link to our website, login information, and instructions will be mailed to participants. We ask participants to watch the DVD, read printed materials, use the website, and follow instructions. Materials are expected to help participants in their caregiver role.
- After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Moffett Field, California, United States, 94035-0128
- Photozig, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Care for an individual with Alzheimer's Disease or other dementia.
- Own a DVD player or have Internet access.
- Minimum age of 21 years old.
- Spend at least 8 hours/week caring for a person with dementia, which may include assisting, watching, monitoring, or being available to help (e.g. during sleep time).
Exclusion Criteria:
- Severe psychological or physical illness.
- Inability to read and follow English instructions.
- High level of depressive symptoms.
- Unwillingness to participate in all aspects of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT-based
CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
|
Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.
|
Active Comparator: Educational/Resources Materials
Educational/Resources Materials: video, workbook, and website.
|
Participants will receive a traditional educational/resources program, containing videos, workbook, and website.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: 3 months
|
The "Perceived Stress Scale" measures the overall level of stress.
This instrument contains 10 items accessing overall appraisals of stress in the past month.
The scale refers to the caregiver.
Minimum score (best value)=0.
Maximum score (worst value)=40.
Higher values represent a worse outcome.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Memory and Behavior Problems Checklist
Time Frame: 3 months
|
This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month.
Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them.
A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred.
The scale refers to the caregiver.
Minimum score (best value)=0.
Maximum score (worst value)=4.
Higher values represent a worse outcome.
|
3 months
|
Perceived Quality of Life
Time Frame: 3 months
|
The "Perceived Quality of Life" (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs.
This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life.
The scale contains items describing level of satisfaction with needs and resources in various categories.
The scale refers to the caregiver.
Minimum (worst value) = 0. Maximum score (best value=10.
Higher values represent a better outcome.
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pz-A103a
- R44AG032762 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on CBT-based program for dementia caregivers
-
National Taipei University of Nursing and Health...Recruiting
-
The University of Hong KongNot yet recruitingDepressive Symptoms | BPSD | Expressed Emotion
-
Chinese University of Hong KongUnknown
-
Gazi UniversityNot yet recruitingCaregivers With a Child Followed up With a Cancer DiagnosisTurkey
-
University Hospital, BordeauxCompletedNeonatal Intensive CareFrance
-
Dr Caeymaex LaurenceMinistry of Health, France; Paris 12 Val de Marne UniversityCompletedNosocomial Pneumonia | Extravasation Injury | Skin Lesion | Intubation Complication | Intensive Care Units, Neonatal | Misadventures to Patients During Surgical and Medical Care | Catheter-related Bloodstream Infection (CRBSI) Nos | Quality of Healthcare | Ventilator Adverse Event | Immature Newborn | Nasal... and other conditionsFrance
-
US Department of Veterans AffairsCompletedParkinson's Disease | Neurological Disorders | Psychological AdaptationUnited States
-
Kaiser PermanenteNorthwestern University; Duke University; Essentia Health; Georgia State UniversityActive, not recruiting
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
Universidad de GranadaCompletedEmotional Stress | Performance AnxietySpain