Trial Outcomes & Findings for Online Caregiver Psychoeducation and Support for Alzheimer's (NCT NCT00416078)
NCT ID: NCT00416078
Last Updated: 2015-04-29
Results Overview
Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.
COMPLETED
PHASE2/PHASE3
53 participants
baseline to end-of-treatment (6 months)
2015-04-29
Participant Flow
Participant milestones
| Measure |
Caregiver Website
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
24
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Caregiver Website
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Online Caregiver Psychoeducation and Support for Alzheimer's
Baseline characteristics by cohort
| Measure |
Caregiver Website
n=29 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=24 Participants
relative supportive telephone calls for six months embedded in one year customary care
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.69 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
81.4 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
79.92 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 patient participants
n=5 Participants
|
19 patient participants
n=7 Participants
|
39 patient participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
6 patient participants
n=5 Participants
|
4 patient participants
n=7 Participants
|
10 patient participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 patient participants
n=5 Participants
|
1 patient participants
n=7 Participants
|
2 patient participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 patient participants
n=5 Participants
|
0 patient participants
n=7 Participants
|
2 patient participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
24 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to end-of-treatment (6 months)Population: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)
Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.
Outcome measures
| Measure |
Caregiver Website
n=20 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=19 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Change in Caregiver Burden From Baseline
baseline
|
32.04 units on a scale
Standard Error 1.95
|
28.59 units on a scale
Standard Error 2.01
|
|
Change in Caregiver Burden From Baseline
end of treatment
|
32.52 units on a scale
Standard Error 2.13
|
27.55 units on a scale
Standard Error 2.19
|
PRIMARY outcome
Timeframe: baseline to end of treatment (6 months)Population: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)
Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.
Outcome measures
| Measure |
Caregiver Website
n=20 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=20 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
baseline
|
30.69 units on a scale
Standard Error 2.89
|
33.04 units on a scale
Standard Error 2.99
|
|
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
end-of-treatment (6 months)
|
33.28 units on a scale
Standard Error 3.11
|
34.75 units on a scale
Standard Error 3.27
|
PRIMARY outcome
Timeframe: baseline to end of treatment (6 months)Population: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)
Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.
Outcome measures
| Measure |
Caregiver Website
n=20 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=20 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
baseline
|
16.04 units on a scale
Standard Error 3.00
|
19.09 units on a scale
Standard Error 3.08
|
|
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
end-of-treatment (6 months)
|
20.23 units on a scale
Standard Error 3.38
|
20.08 units on a scale
Standard Error 3.57
|
PRIMARY outcome
Timeframe: baseline to end-of-treatment (6 months)Population: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)
Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression
Outcome measures
| Measure |
Caregiver Website
n=19 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=21 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Change in Caregiver Depression From Baseline
baseline
|
9.27 units on a scale
Standard Error 1.54
|
9.20 units on a scale
Standard Error 1.63
|
|
Change in Caregiver Depression From Baseline
end of treatment
|
8.61 units on a scale
Standard Error 1.73
|
9.43 units on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: baseline to end-of-treatment (6 months)Population: measure was added to study while in process
Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.
Outcome measures
| Measure |
Caregiver Website
n=9 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=16 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Change in Caregiver Report of Patient Medication Adherence From Baseline
at baseline
|
4.63 units on a 1-5 scale
Standard Error .47
|
4.06 units on a 1-5 scale
Standard Error .42
|
|
Change in Caregiver Report of Patient Medication Adherence From Baseline
at 6 months
|
5.08 units on a 1-5 scale
Standard Error .75
|
3.94 units on a 1-5 scale
Standard Error .44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to end-of-follow-up (12 months from baseline)Population: Numbers vary; patients only at risk for out-of-home placement if alive and with data during follow-up periods
Frequency count of individuals placed in assisted living or nursing homes
Outcome measures
| Measure |
Caregiver Website
n=18 Participants
relative access to website support for 6 months embedded in one year of customary care
|
Caregiver Phone Calls
n=16 Participants
relative supportive telephone calls for six months embedded in one year of customary care
|
|---|---|---|
|
Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline
|
2 participants
|
3 participants
|
Adverse Events
Caregiver Website Support
Caregiver Brief Supportive Phone Calls
Serious adverse events
| Measure |
Caregiver Website Support
n=29 participants at risk
caregiver access to website support for 6 months embedded in one year of customary care
|
Caregiver Brief Supportive Phone Calls
n=24 participants at risk
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
|
|---|---|---|
|
Nervous system disorders
fatal
|
10.3%
3/29 • Number of events 3 • Baseline through 12 months
|
16.7%
4/24 • Number of events 4 • Baseline through 12 months
|
|
General disorders
Hospitalization
|
3.4%
1/29 • Number of events 1 • Baseline through 12 months
|
4.2%
1/24 • Number of events 1 • Baseline through 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place