Alzheimer Disease, Mild Cognitive Impairment
Conditions
Brief summary
The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Mild Cognitive Impairment or Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.
Interventions
BEHAVIORALA Program of SUPPORT-D (dementia)
The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG. * Persons with Alzheimer's Disease (investigators anticipate cognitive impairment within this group) * 18 years old or older * Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease (FAST score \< 4) * Able to read and speak English (intervention in English) Caregivers (CG) * \> 18 years old * Non-paid (eliminates professional caregivers) * Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report) * Able to read and speak English (written materials in English) * No diagnosis of cognitive impairment
Exclusion criteria
* Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alzheimer's Disease Knowledge Scale (ADKS) Score | baseline, at study completion, an average of 8 weeks | 30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30) |
| Acceptability of Intervention Measure (AIM) Score | at study completion, an average of 8 weeks | 4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20) |
| Feasibility Score | at study completion, an average of 8 weeks | 4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20) |
| Change Zarit Caregiver Burden Score | baseline, at study completion, an average of 8 weeks | 12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48) |
| Change in Perceived Stress Scale Score | baseline and at study completion, an average of 8 weeks | 10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40) |
| Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score | baseline and at study completion, an average of 8 weeks | 13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52) |
| Change in Self-efficacy for Caregiving Score | baseline and at study completion, an average of 8 weeks | 8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80) |
| Change in Safety Assessment Scale Score | baseline and at study completion, an average of 8 weeks | 16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks. |
| Appropriateness of Intervention Score | at study completion, an average of 8 weeks | 4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caregiver Group A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). | 29 |
| Care Recipient Group A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks). | 27 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Caregiver Group | Total | Care Recipient Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 49 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 7 Participants | 6 Participants |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 10.3 | 72.4 years STANDARD_DEVIATION 9.6 | 75.1 years STANDARD_DEVIATION 8.3 |
| Alzheimer's Disease Knowledge Scale | 25.18 units on a scale STANDARD_DEVIATION 2.45 | 23.1 units on a scale STANDARD_DEVIATION 2.27 | 20.36 units on a scale STANDARD_DEVIATION 5.38 |
| Caregiver Self-efficacy Scale | 6.67 units on a scale STANDARD_DEVIATION 1.7 | 6.67 units on a scale STANDARD_DEVIATION 1.7 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 52 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Perceived Stress Scale | 20.50 units on a scale STANDARD_DEVIATION 4.51 | 18.3 units on a scale STANDARD_DEVIATION 5.31 | 16.18 units on a scale STANDARD_DEVIATION 5.91 |
| Quality of Life in Alzheimer's Disease Scale | 34.61 units on a scale STANDARD_DEVIATION 7.26 | 36.64 units on a scale STANDARD_DEVIATION 7.59 | 39.23 units on a scale STANDARD_DEVIATION 7.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 51 Participants | 26 Participants |
| Region of Enrollment United States | 29 participants | 56 participants | 27 participants |
| Safety Assessment Scale | 30.32 units on a scale STANDARD_DEVIATION 5.98 | 30.32 units on a scale STANDARD_DEVIATION 5.98 | — |
| Sex: Female, Male Female | 23 Participants | 31 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 25 Participants | 19 Participants |
| Zarit Burden Interview | 18.21 units on a scale STANDARD_DEVIATION 9.19 | 18.21 units on a scale STANDARD_DEVIATION 9.19 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 |
| other Total, other adverse events | 0 / 28 | 0 / 22 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 |
Outcome results
Primary
Acceptability of Intervention Measure (AIM) Score
4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20)
Time frame: at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Acceptability of Intervention Measure (AIM) Score | 4.36 score on a scale | Standard Deviation 0.5 |
| Care Recipient Group | Acceptability of Intervention Measure (AIM) Score | 3.51 score on a scale | Standard Deviation 1.18 |
Primary
Appropriateness of Intervention Score
4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20)
Time frame: at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Appropriateness of Intervention Score | 4.33 units on a scale | Standard Deviation 0.58 |
| Care Recipient Group | Appropriateness of Intervention Score | 4.05 units on a scale | Standard Deviation 0.71 |
Primary
Change in Alzheimer's Disease Knowledge Scale (ADKS) Score
30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30)
Time frame: baseline, at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change in Alzheimer's Disease Knowledge Scale (ADKS) Score | 0.26 score on a scale | Standard Deviation 1.74 |
| Care Recipient Group | Change in Alzheimer's Disease Knowledge Scale (ADKS) Score | 1.15 score on a scale | Standard Deviation 3.8 |
Primary
Change in Perceived Stress Scale Score
10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40)
Time frame: baseline and at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change in Perceived Stress Scale Score | -0.09 score on a scale | Standard Deviation 3.18 |
| Care Recipient Group | Change in Perceived Stress Scale Score | 1.38 score on a scale | Standard Deviation 6.93 |
Primary
Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score
13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52)
Time frame: baseline and at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score | -0.74 score on a scale | Standard Error 3.73 |
| Care Recipient Group | Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score | -0.08 score on a scale | Standard Error 6.4 |
Primary
Change in Safety Assessment Scale Score
16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks.
Time frame: baseline and at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change in Safety Assessment Scale Score | 0.09 score on a scale | Standard Deviation 4.17 |
Primary
Change in Self-efficacy for Caregiving Score
8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80)
Time frame: baseline and at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change in Self-efficacy for Caregiving Score | 0.54 score on a scale | Standard Deviation 1.02 |
Primary
Change Zarit Caregiver Burden Score
12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48)
Time frame: baseline, at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Change Zarit Caregiver Burden Score | -1.09 score on a scale | Standard Deviation 5.02 |
Primary
Feasibility Score
4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20)
Time frame: at study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Group | Feasibility Score | 4.24 score on a scale | Standard Deviation 0.7 |
| Care Recipient Group | Feasibility Score | 4.05 score on a scale | Standard Deviation 0.75 |