iCare Stress Management e-Training for Dementia Family Caregivers
This study has been completed.
Sponsor:
Photozig, Inc.
Collaborators:
Stanford University
Information provided by (Responsible Party):
Photozig, Inc.
ClinicalTrials.gov Identifier:
NCT01378195
First received: June 17, 2011
Last updated: February 22, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: August 30, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care |
| Conditions: |
Alzheimer's Disease Dementia |
| Interventions: |
Behavioral: CBT-based program for dementia caregivers Behavioral: Educational/Resources program |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Dates of recruitment period: May 2011 to March 2012 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participant assignment to group was random. |
Reporting Groups
| Description | |
|---|---|
| CBT-based | CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website |
| Educational/Resources Materials | Educational/Resources Materials: video, workbook, and website. |
Participant Flow: Overall Study
| CBT-based | Educational/Resources Materials | |
|---|---|---|
| STARTED | 75 | 75 |
| COMPLETED | 46 | 57 |
| NOT COMPLETED | 29 | 18 |
| Lost to Follow-up | 29 | 18 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| CBT-based | CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website |
| Educational/Resources Materials | Educational/Resources Materials: video, workbook, and website. |
| Total | Total of all reporting groups |
Baseline Measures
| CBT-based | Educational/Resources Materials | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
75 | 75 | 150 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 47 | 48 | 95 |
| >=65 years | 28 | 27 | 55 |
|
Gender
[units: participants] |
|||
| Female | 59 | 66 | 125 |
| Male | 16 | 9 | 25 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 75 | 75 | 150 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Perceived Stress Scale [ Time Frame: 3 months ] |
| 2. Secondary: | Revised Memory and Behavior Problems Checklist [ Time Frame: 3 months ] |
| 3. Secondary: | Perceived Quality of Life [ Time Frame: 3 months ] |
Hide Outcome Measure 3
| Measure Type | Secondary |
|---|---|
| Measure Title | Perceived Quality of Life |
| Measure Description | 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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| CBT-based | CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website |
| Educational/Resources Materials | Educational/Resources Materials: video, workbook, and website. |
Measured Values
| CBT-based | Educational/Resources Materials | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 57 |
|
Perceived Quality of Life
[units: units on a scale] Mean ± Standard Deviation |
6.34 ± 1.54 | 6.31 ± 1.84 |
No statistical analysis provided for Perceived Quality of Life
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Results Point of Contact:
Name/Title: Bruno Kajiyama
Organization: Photozig, Inc.
phone: 650-694-7496
e-mail: info@photozig.com
Organization: Photozig, Inc.
phone: 650-694-7496
e-mail: info@photozig.com
No publications provided
| Responsible Party: | Photozig, Inc. |
| ClinicalTrials.gov Identifier: | NCT01378195 History of Changes |
| Other Study ID Numbers: | Pz-A103a, R44AG032762 |
| Study First Received: | June 17, 2011 |
| Results First Received: | August 30, 2012 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Institutional Review Board |