Trial Outcomes & Findings for Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study (NCT NCT02092987)
NCT ID: NCT02092987
Last Updated: 2021-07-09
Results Overview
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The GDS questions are answered "yes" or "no", instead of a five-category response set. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".Higher scores indicate more depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
6 months
Results posted on
2021-07-09
Participant Flow
Participant milestones
| Measure |
NYU Caregiver Intervention
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
111
|
|
Overall Study
COMPLETED
|
106
|
103
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
Baseline characteristics by cohort
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.15 Years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
58.33 Years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
58.24 Years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
110 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
111 participants
n=7 Participants
|
221 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The GDS questions are answered "yes" or "no", instead of a five-category response set. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".Higher scores indicate more depressive symptoms.
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on Geriatric Depression Scale
|
9.57 units on a scale
Standard Deviation 7.12
|
9.80 units on a scale
Standard Deviation 7.25
|
PRIMARY outcome
Timeframe: 6 monthsZarit Caregiver Burden Scale measures caregiver burden by asking caregivers to respond to a series of 22 questions about the impact of the patient's disabilities on their life. For each item, caregivers are to indicate how often they felt that way (never, rarely, sometimes, quite frequently, or nearly always). The Burden Interview is scored by adding the numbered responses of the individual items. Higher scores indicate greater caregiver distress. Estimates of the degree of burden can be made from preliminary findings: 0 - 20 (little or no burden), 21 - 40 (mild to moderate burden), 41 - 60 (moderate to severe burden), and 61 - 88 (severe burden).
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on Zarit Caregiver Burden Scale
|
36.24 units on a scale
Standard Deviation 15.88
|
35.46 units on a scale
Standard Deviation 18.04
|
SECONDARY outcome
Timeframe: 6 monthsThe Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale: For adults, each question has five response options ranging in value from one to five (for pediatrics and parent proxy it is 0 to 4). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Higher scores indicate better health.
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale
|
30.10 T-score
Standard Deviation 8.36
|
28.68 T-score
Standard Deviation 7.38
|
SECONDARY outcome
Timeframe: 6 monthsThe Perceived Stress Scale is a self-report measure of stress that would be used to measure caregiver stress. The total score is calculated by finding the sum of 10 items, reverse coding questions 4, 5, 7, \& 8. The PSS has a range of scores between 0 and 40. A higher score indicates more stress.
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on Perceived Stress Scale (PSS)
|
14.98 units on a scale
Standard Deviation 8.10
|
14.95 units on a scale
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: 6 monthsDepressive symptoms measured with the PROMIS SF Depression Scale: Each question has five response options ranging in value from one to five. To find the total raw score, sum the values of the response to each question. For example, for the eight-item form, the lowest possible raw score is 8; the highest possible raw score is 40. The total raw score is then converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score means more depressive symptoms.
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on the PROMIS Short Form (SF) Depression Scale
|
48.01 T-score
Standard Deviation 10.32
|
48.51 T-score
Standard Deviation 10.28
|
SECONDARY outcome
Timeframe: 6 monthsThe PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. The range of the total score of the PHQ-9 is 0 to 27, with higher scores indicating more depressive symptoms.
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Total Score on Patient Health Questionnaire (PHQ-9)
|
5.40 score on a scale
Standard Deviation 5.40
|
4.73 score on a scale
Standard Deviation 4.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe Lawton Caregiver Appraisal Scale burden subscale has 9 items. Items include "Do you feel that because of the time you spend with your Elder that you don't have enough time for yourself?", "Do you feel your health has suffered because of your involvement with your Elder?," "Do you feel that your social life has suffered because you are caring for your Elder?", "Do you feel that you will be unable to take care of your Elder much longer?", "Do you feel you have lost control of your life since your Elder's illness?", "Do you feel very tired as a result of caring for your Elder?", "Do you feel isolated and alone as a result of caring for your Elder?", "Taking care of my Elder gives me a trapped feeling", and "I can fit in most of the things I need to do in spite of the time taken by caring for my Elder". The five-point Likert scale responses ranged from "never" to "nearly always." The score ranges from 5 to 45; higher score indicates greater burden
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on the Lawton Caregiving Appraisal Scale (CAS) - Burden Subscale
|
23.42 score on a scale
Standard Deviation 8.72
|
23.73 score on a scale
Standard Deviation 9.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe Montgomery Caregiving Objective Burden Scale consists of 6 items. Caregivers are asked if caregiving responsibilities have "decreased time you have to yourself", "given you little time for friends and relatives", "caused your social like to suffer", "changed your routine", "left you with almost no time to relax", and "kept you from recreational activities". Items were rated on a five point Likert scale ranging from "not at all" to "a great deal". The score ranges from 5 to 30; Higher score indicates greater burden
Outcome measures
| Measure |
NYU Caregiver Intervention
n=110 Participants
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services
Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
|
REACH OUT
n=111 Participants
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed.
Social work support: All study participants will be provided access to social support services at Riverstone Senior Life services Educational material: All participants receive educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, a
|
|---|---|---|
|
Score on Montgomery Objective Burden Scale
|
18.00 score on a scale
Standard Deviation 7.10
|
17.26 score on a scale
Standard Deviation 6.84
|
Adverse Events
NYU Caregiver Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
REACH OUT
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place