Caregivers of Alzheimer's Disease or Memory Problem Patients
Conditions
Keywords
Alzheimer's caregivers, Technology-based intervention, Culturally-tailored intervention
Brief summary
The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.
Interventions
BEHAVIORALCaregiving condition
The intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes.
BEHAVIORALNutrition condition
The intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided.
Sponsors
National Institute of Nursing Research (NINR)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Speak and understand English or Spanish 2. Provide care to a loved one with memory decline 3. Not having terminal illness/condition 4. 18+ yrs old
Exclusion criteria
1. Not providing care to a loved one with Alzheimer disease or dementia 2. Not speak English or Spanish 3. Have cognitive deficit 4. Have terminal illness 5. Plan to place their loved one in a facility 6. Plan to move away in the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline, 6-mth follow-up and 12-mth follow-up | CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms. |
| Caregiving Burden as Measured by Burden Inventory | Baseline, 6-mth follow-up and 12-mth follow-up | Higher score means greater level of caregiver burden. Range (0-44) |
| Caregiver's Self Report of Self-care | Baseline, 6-mth follow-up and 12-mth follow-up | A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself. |
| Caregiver's Self-report of Physical Health | Baseline, 6-mth follow-up and 12-mth follow-up | SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health. |
| Caregiver's Self-efficacy | Baseline, 6-mth follow-up and 12-mth follow-up | A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy. |
| Positive Aspects of Caregiving | Baseline, 6-mth follow-up and 12-mth follow-up | An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caregiving Condition Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition | 123 |
| Nutrition Condition Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition | 121 |
| Total | 244 |
Baseline characteristics
| Characteristic | Total | Nutrition Condition | Caregiving Condition |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 94 Participants | 39 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 82 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 109 Participants | 54 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 67 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 26 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) White | 174 Participants | 89 Participants | 85 Participants |
| Sex: Female, Male Female | 204 Participants | 101 Participants | 103 Participants |
| Sex: Female, Male Male | 40 Participants | 20 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Caregiver's Self-efficacy
A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Caregiver's Self-efficacy | Baseline | 925.21 percentage of efficacy | Standard Deviation 243.36 |
| Caregiving Condition | Caregiver's Self-efficacy | 6 month follow up | 971.43 percentage of efficacy | Standard Deviation 295.41 |
| Caregiving Condition | Caregiver's Self-efficacy | 12 month follow up | 999.65 percentage of efficacy | Standard Deviation 285.94 |
| Nutrition Condition | Caregiver's Self-efficacy | 12 month follow up | 1047.71 percentage of efficacy | Standard Deviation 225.14 |
| Nutrition Condition | Caregiver's Self-efficacy | Baseline | 936.65 percentage of efficacy | Standard Deviation 249.62 |
| Nutrition Condition | Caregiver's Self-efficacy | 6 month follow up | 964.15 percentage of efficacy | Standard Deviation 273.06 |
Primary
Caregiver's Self-report of Physical Health
SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Caregiver's Self-report of Physical Health | Baseline | 2.71 score on a scale | Standard Deviation 1.03 |
| Caregiving Condition | Caregiver's Self-report of Physical Health | 6 month follow up | 2.89 score on a scale | Standard Deviation 1.12 |
| Caregiving Condition | Caregiver's Self-report of Physical Health | 12 month follow up | 2.76 score on a scale | Standard Deviation 1.09 |
| Nutrition Condition | Caregiver's Self-report of Physical Health | Baseline | 2.75 score on a scale | Standard Deviation 1.14 |
| Nutrition Condition | Caregiver's Self-report of Physical Health | 6 month follow up | 2.51 score on a scale | Standard Deviation 1.11 |
| Nutrition Condition | Caregiver's Self-report of Physical Health | 12 month follow up | 2.67 score on a scale | Standard Deviation 1.22 |
Primary
Caregiver's Self Report of Self-care
A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Caregiver's Self Report of Self-care | Baseline | 0.62 score on a scale | Standard Deviation 0.18 |
| Caregiving Condition | Caregiver's Self Report of Self-care | 6 month follow up | 0.62 score on a scale | Standard Deviation 0.18 |
| Caregiving Condition | Caregiver's Self Report of Self-care | 12 month follow up | 0.62 score on a scale | Standard Deviation 0.2 |
| Nutrition Condition | Caregiver's Self Report of Self-care | Baseline | 0.60 score on a scale | Standard Deviation 0.17 |
| Nutrition Condition | Caregiver's Self Report of Self-care | 6 month follow up | 0.60 score on a scale | Standard Deviation 0.17 |
| Nutrition Condition | Caregiver's Self Report of Self-care | 12 month follow up | 0.61 score on a scale | Standard Deviation 0.17 |
Primary
Caregiving Burden as Measured by Burden Inventory
Higher score means greater level of caregiver burden. Range (0-44)
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Caregiving Burden as Measured by Burden Inventory | Baseline | 18.52 score on a scale | Standard Deviation 8.91 |
| Caregiving Condition | Caregiving Burden as Measured by Burden Inventory | 6 month follow up | 16.89 score on a scale | Standard Deviation 8.39 |
| Caregiving Condition | Caregiving Burden as Measured by Burden Inventory | 12 month follow up | 16.08 score on a scale | Standard Deviation 8.29 |
| Nutrition Condition | Caregiving Burden as Measured by Burden Inventory | Baseline | 19.66 score on a scale | Standard Deviation 7.59 |
| Nutrition Condition | Caregiving Burden as Measured by Burden Inventory | 6 month follow up | 18.23 score on a scale | Standard Deviation 6.97 |
| Nutrition Condition | Caregiving Burden as Measured by Burden Inventory | 12 month follow up | 17.66 score on a scale | Standard Deviation 8.27 |
Primary
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 11.38 score on a scale | Standard Deviation 7.02 |
| Caregiving Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | 6 month follow up | 10.86 score on a scale | Standard Deviation 6.63 |
| Caregiving Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | 12 month follow up | 10.32 score on a scale | Standard Deviation 7.18 |
| Nutrition Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 10.88 score on a scale | Standard Deviation 5.79 |
| Nutrition Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | 6 month follow up | 10.69 score on a scale | Standard Deviation 6.23 |
| Nutrition Condition | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | 12 month follow up | 10.46 score on a scale | Standard Deviation 6.25 |
Primary
Positive Aspects of Caregiving
An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Population: Follow up visits were not completed for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiving Condition | Positive Aspects of Caregiving | Baseline | 24.46 score on a scale | Standard Deviation 8.49 |
| Caregiving Condition | Positive Aspects of Caregiving | 6 month follow up | 24.72 score on a scale | Standard Deviation 8.34 |
| Caregiving Condition | Positive Aspects of Caregiving | 12 month follow up | 24.00 score on a scale | Standard Deviation 9.6 |
| Nutrition Condition | Positive Aspects of Caregiving | Baseline | 23.24 score on a scale | Standard Deviation 8.83 |
| Nutrition Condition | Positive Aspects of Caregiving | 6 month follow up | 24.02 score on a scale | Standard Deviation 8.54 |
| Nutrition Condition | Positive Aspects of Caregiving | 12 month follow up | 24.58 score on a scale | Standard Deviation 8.54 |