Trial Outcomes & Findings for iCare Stress Management e-Training for Dementia Family Caregivers (NCT NCT01378195)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

3 months

Results posted on

2013-02-28

Participant Flow

Dates of recruitment period: May 2011 to March 2012

Participant assignment to group was random.

Participant milestones

Participant milestones
Measure	CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials Educational/Resources Materials: video, workbook, and website.
Overall Study STARTED	75	75
Overall Study COMPLETED	46	57
Overall Study NOT COMPLETED	29	18

Reasons for withdrawal

Reasons for withdrawal
Measure	CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials Educational/Resources Materials: video, workbook, and website.
Overall Study Lost to Follow-up	29	18

Baseline Characteristics

iCare Stress Management e-Training for Dementia Family Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT-based n=75 Participants CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials n=75 Participants Educational/Resources Materials: video, workbook, and website.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	66 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT-based n=46 Participants CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials n=57 Participants Educational/Resources Materials: video, workbook, and website.
Perceived Stress Scale	15.83 units on a scale Standard Deviation 5.07	16.41 units on a scale Standard Deviation 7.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT-based n=46 Participants CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials n=57 Participants Educational/Resources Materials: video, workbook, and website.
Revised Memory and Behavior Problems Checklist	0.83 units on a scale Standard Deviation 0.63	0.91 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CBT-based n=46 Participants CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Educational/Resources Materials n=57 Participants Educational/Resources Materials: video, workbook, and website.
Perceived Quality of Life	6.34 units on a scale Standard Deviation 1.54	6.31 units on a scale Standard Deviation 1.84

Adverse Events

CBT-based

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational/Resources Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruno Kajiyama

Photozig, Inc.

Phone: 650-694-7496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place