Trial Outcomes & Findings for A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program) (NCT NCT03333252)
NCT ID: NCT03333252
Last Updated: 2024-04-02
Results Overview
Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
352 participants
Primary outcome timeframe
Baseline, 6-mth follow-up and 12-mth follow-up
Results posted on
2024-04-02
Participant Flow
Participant milestones
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks.
|
Care Recipients - Control
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
Exposing caregivers to caregiving-related information.
|
Caregivers - Control
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
87
|
89
|
87
|
|
Overall Study
COMPLETED
|
56
|
45
|
64
|
58
|
|
Overall Study
NOT COMPLETED
|
33
|
42
|
25
|
29
|
Reasons for withdrawal
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks.
|
Care Recipients - Control
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
Exposing caregivers to caregiving-related information.
|
Caregivers - Control
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
5
|
2
|
|
Overall Study
Death
|
1
|
3
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
8
|
4
|
0
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
9
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
24
|
11
|
17
|
Baseline Characteristics
The primary outcome listed in the submission is caregiver specific.
Baseline characteristics by cohort
| Measure |
Care Recipients - Intervention Condition
n=89 Participants
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
n=87 Participants
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 Participants
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
n=87 Participants
Exposing caregivers to Nutrition and Health promotional material.
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=352 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=89 Participants
|
3 Participants
n=87 Participants
|
43 Participants
n=89 Participants
|
36 Participants
n=87 Participants
|
83 Participants
n=352 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=89 Participants
|
84 Participants
n=87 Participants
|
46 Participants
n=89 Participants
|
51 Participants
n=87 Participants
|
269 Participants
n=352 Participants
|
|
Age, Continuous
|
81 years
n=89 Participants
|
81 years
n=87 Participants
|
65 years
n=89 Participants
|
67 years
n=87 Participants
|
75 years
n=352 Participants
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=89 Participants
|
34 Participants
n=87 Participants
|
74 Participants
n=89 Participants
|
76 Participants
n=87 Participants
|
224 Participants
n=352 Participants
|
|
Sex/Gender, Customized
Male
|
49 Participants
n=89 Participants
|
52 Participants
n=87 Participants
|
15 Participants
n=89 Participants
|
11 Participants
n=87 Participants
|
127 Participants
n=352 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=89 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=89 Participants
|
19 Participants
n=87 Participants
|
19 Participants
n=89 Participants
|
18 Participants
n=87 Participants
|
72 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=89 Participants
|
68 Participants
n=87 Participants
|
70 Participants
n=89 Participants
|
69 Participants
n=87 Participants
|
280 Participants
n=352 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=352 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=89 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
4 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
9 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=89 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=89 Participants
|
8 Participants
n=87 Participants
|
6 Participants
n=89 Participants
|
7 Participants
n=87 Participants
|
28 Participants
n=352 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=89 Participants
|
70 Participants
n=87 Participants
|
77 Participants
n=89 Participants
|
73 Participants
n=87 Participants
|
295 Participants
n=352 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=352 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=89 Participants
|
7 Participants
n=87 Participants
|
2 Participants
n=89 Participants
|
7 Participants
n=87 Participants
|
18 Participants
n=352 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=89 Participants
|
87 participants
n=87 Participants
|
89 participants
n=89 Participants
|
87 participants
n=87 Participants
|
352 participants
n=352 Participants
|
|
Change in depression score for caregiver as measured by CES-D
|
—
|
—
|
9 units on a scale
n=89 Participants • The primary outcome listed in the submission is caregiver specific.
|
10 units on a scale
n=87 Participants • The primary outcome listed in the submission is caregiver specific.
|
10 units on a scale
n=176 Participants • The primary outcome listed in the submission is caregiver specific.
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: This measure was only administered to caregivers. Missing data is due to participants either lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 Participants
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
n=87 Participants
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Depression Score for Caregiver as Measured by CES-D
baseline
|
—
|
—
|
9 units on a scale
Interval 7.0 to 14.0
|
10 units on a scale
Interval 7.0 to 13.0
|
|
Change in Depression Score for Caregiver as Measured by CES-D
6 month
|
—
|
—
|
9 units on a scale
Interval 6.7 to 12.0
|
8 units on a scale
Interval 5.5 to 11.0
|
|
Change in Depression Score for Caregiver as Measured by CES-D
12 month
|
—
|
—
|
9 units on a scale
Interval 6.0 to 13.0
|
9 units on a scale
Interval 7.0 to 12.0
|
SECONDARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: This measure was only administered to caregivers. Additionally, missing data is due to some participants either being lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score means greater level of caregiver burden. Range (0-44)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 Participants
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
n=87 Participants
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
Baseline
|
—
|
—
|
18 score on a scale
Interval 13.0 to 26.0
|
18 score on a scale
Interval 12.0 to 25.0
|
|
Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
6 month
|
—
|
—
|
16 score on a scale
Interval 9.8 to 22.0
|
15 score on a scale
Interval 9.4 to 23.5
|
|
Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
12 month
|
—
|
—
|
15.6 score on a scale
Interval 9.0 to 25.0
|
17 score on a scale
Interval 11.0 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score means better in keeping medical obligations to him/herself. Range (0-12)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 Participants
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
n=87 Participants
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Caregiver's Self Report of Self-care
Baseline
|
—
|
—
|
6 units on a scale
Interval 4.8 to 8.7
|
6 units on a scale
Interval 4.0 to 8.4
|
|
Change in Caregiver's Self Report of Self-care
6 month
|
—
|
—
|
6.6 units on a scale
Interval 4.8 to 8.4
|
6 units on a scale
Interval 4.8 to 7.0
|
|
Change in Caregiver's Self Report of Self-care
12 month
|
—
|
—
|
8 units on a scale
Interval 6.8 to 8.7
|
8 units on a scale
Interval 6.8 to 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score means more social support for the caregiver. Range (0-40)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 Participants
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
n=87 Participants
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Caregiver's Social Support
Baseline
|
—
|
—
|
22 units on a scale
Interval 17.1 to 29.0
|
23 units on a scale
Interval 18.7 to 29.0
|
|
Change in Caregiver's Social Support
6 month
|
—
|
—
|
21 units on a scale
Interval 17.0 to 28.6
|
23 units on a scale
Interval 17.0 to 28.0
|
|
Change in Caregiver's Social Support
12 month
|
—
|
—
|
21.5 units on a scale
Interval 15.0 to 27.5
|
22 units on a scale
Interval 16.5 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-mth follow-up, and 12-mth follow-upPopulation: This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score means better quality of life as Alzheimer's patient. Range (0-52)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
n=87 Participants
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
n=87 Participants
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Care Recipient's Qualify of Life
Baseline
|
33 units on a scale
Interval 29.0 to 36.0
|
32 units on a scale
Interval 28.6 to 36.0
|
—
|
—
|
|
Change in Care Recipient's Qualify of Life
6 month
|
33 units on a scale
Interval 29.0 to 36.0
|
32 units on a scale
Interval 29.0 to 36.0
|
—
|
—
|
|
Change in Care Recipient's Qualify of Life
12 month
|
33 units on a scale
Interval 29.3 to 37.0
|
33 units on a scale
Interval 30.0 to 36.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6-mth follow-up, and 12-mth follow-upPopulation: This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.
Higher score means faster processing speed. Range (0-100)
Outcome measures
| Measure |
Care Recipients - Intervention Condition
n=54 Participants
Exposing care recipients to cognitive training tasks
|
Care Recipients - Control Condition
n=47 Participants
Exposing care recipients to plain words games from computer.
|
Caregivers - Intervention Condition
Exposing caregivers to caregiving-related information.
|
Caregivers - Control Condition
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Change in Care Recipient's Processing Speed Using Digit Symbol Test
12 months
|
20 units on a scale
Interval 14.0 to 32.0
|
23 units on a scale
Interval 13.0 to 30.0
|
—
|
—
|
|
Change in Care Recipient's Processing Speed Using Digit Symbol Test
Baseline
|
15 units on a scale
Interval 9.0 to 28.0
|
27 units on a scale
Interval 19.0 to 34.0
|
—
|
—
|
|
Change in Care Recipient's Processing Speed Using Digit Symbol Test
6 months
|
25 units on a scale
Interval 14.0 to 30.0
|
28 units on a scale
Interval 15.0 to 31.0
|
—
|
—
|
Adverse Events
Care Recipients - Intervention Condition
Serious events: 11 serious events
Other events: 7 other events
Deaths: 1 deaths
Care Recipients - Control
Serious events: 12 serious events
Other events: 18 other events
Deaths: 3 deaths
Caregivers - Intervention Condition
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Caregivers - Control
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Care Recipients - Intervention Condition
n=89 participants at risk
Exposing care recipients to cognitive training tasks.
|
Care Recipients - Control
n=87 participants at risk
The care recipients are exposed to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 participants at risk
Exposing caregivers to caregiving-related information.
|
Caregivers - Control
n=87 participants at risk
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
General disorders
Emergency Room Visit
|
6.7%
6/89 • Five years
|
8.0%
7/87 • Five years
|
0.00%
0/89 • Five years
|
3.4%
3/87 • Five years
|
|
General disorders
Hospitalized
|
2.2%
2/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
|
General disorders
Driving Impairment
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
General disorders
Access to Dangerous Object
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Musculoskeletal and connective tissue disorders
Hip Replacement
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
General disorders
Institutionalized
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
General disorders
Medical problem
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
|
General disorders
Disease progression
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
Other adverse events
| Measure |
Care Recipients - Intervention Condition
n=89 participants at risk
Exposing care recipients to cognitive training tasks.
|
Care Recipients - Control
n=87 participants at risk
The care recipients are exposed to plain words games from computer.
|
Caregivers - Intervention Condition
n=89 participants at risk
Exposing caregivers to caregiving-related information.
|
Caregivers - Control
n=87 participants at risk
Exposing caregivers to Nutrition and Health promotional material.
|
|---|---|---|---|---|
|
Psychiatric disorders
Self-reported depression
|
1.1%
1/89 • Five years
|
9.2%
8/87 • Five years
|
29.2%
26/89 • Five years
|
17.2%
15/87 • Five years
|
|
General disorders
Allergic reaction
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Musculoskeletal and connective tissue disorders
Broken back
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
General disorders
Health problems
|
0.00%
0/89 • Five years
|
2.3%
2/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Injury, poisoning and procedural complications
Forehead injury
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Cardiac disorders
Heart condition
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Surgical and medical procedures
Heart surgery
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Infections and infestations
Urinary tract infection
|
3.4%
3/89 • Five years
|
2.3%
2/87 • Five years
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
|
Eye disorders
Macular Degeneration
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
1/89 • Five years
|
1.1%
1/87 • Five years
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
|
Surgical and medical procedures
Knee surgery
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
0.00%
0/89 • Five years
|
1.1%
1/87 • Five years
|
|
Musculoskeletal and connective tissue disorders
Leg fracture
|
0.00%
0/89 • Five years
|
0.00%
0/87 • Five years
|
1.1%
1/89 • Five years
|
0.00%
0/87 • Five years
|
Additional Information
Sara J. Czaja
Weill Medical College of Cornell University
Phone: 646-962-7141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place