Alzheimer's Disease, Dementia
Conditions
Keywords
Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress
Brief summary
Photozig and Stanford University are creating a program to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. This home-based program includes a free DVD, printed materials, and resource website. In addition, after completing the program, participants will have free access to final online resources for 1 year. There are no face-to-face meetings, and participants can live anywhere in the United States.
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: 1. 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). 2. A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope. 3. 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. 4. After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.
Interventions
BEHAVIORALCBT-based program for dementia caregivers
Participants will receive a CBT-based program \[Cognitive Behavioral Therapy\], containing videos, workbook, and website.
BEHAVIORALEducational/Resources program
Participants will receive a traditional educational/resources program, containing videos, workbook, and website.
Sponsors
Stanford University
National Institute on Aging (NIA)
Photozig, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Memory and Behavior Problems Checklist | 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. |
| Perceived Quality of Life | 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. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: May 2011 to March 2012
Pre-assignment details
Participant assignment to group was random.
Participants by arm
| Arm | Count |
|---|---|
| CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website | 75 |
| Educational/Resources Materials Educational/Resources Materials: video, workbook, and website. | 75 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 29 | 18 |
Baseline characteristics
| Characteristic | CBT-based | Educational/Resources Materials | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 48 Participants | 95 Participants |
| Region of Enrollment United States | 75 participants | 75 participants | 150 participants |
| Sex: Female, Male Female | 59 Participants | 66 Participants | 125 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Perceived Stress Scale
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-based | Perceived Stress Scale | 15.83 units on a scale | Standard Deviation 5.07 |
| Educational/Resources Materials | Perceived Stress Scale | 16.41 units on a scale | Standard Deviation 7.15 |
Secondary
Perceived Quality of Life
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-based | Perceived Quality of Life | 6.34 units on a scale | Standard Deviation 1.54 |
| Educational/Resources Materials | Perceived Quality of Life | 6.31 units on a scale | Standard Deviation 1.84 |
Secondary
Revised Memory and Behavior Problems Checklist
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT-based | Revised Memory and Behavior Problems Checklist | 0.83 units on a scale | Standard Deviation 0.63 |
| Educational/Resources Materials | Revised Memory and Behavior Problems Checklist | 0.91 units on a scale | Standard Deviation 0.75 |