Alzheimer's Disease
Conditions
Keywords
technology development and assessment, internet, randomized control trial
Brief summary
This study is piloting an internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for six month. It is hypothesized that participation in the intensive intervention will result in a reductions in patient problematic behavior and caregiver responses to it, reduced caregiver burden and depression, and improved medication adherence at the end of treatment, and more patients remaining at home through the 12 months post-randomization period..
Detailed description
Alzheimer's disease (AD) is a progressive brain disease resulting in cognitive and functional decline. While some pharmacological agents and behavioral programs are now available to slow the rate of decline, there is no cure. Caregivers, who typically are the female spouses or daughters of afflicted individuals, must confront both the deterioration of a loved one, and that person's need for increasingly demanding care. Caregivers tend to experience high levels of depression, anxiety, and burden. Data suggest that providing education, social support, and ongoing professional consultation to families involved in the care of a relative with AD results in improvement in caregiver psychological status, and sometimes even slows the functional decline of the patient. Recent technological advancements in video conferencing, online communication, and streaming audio/video presentations, which are increasingly easy to use and gaining widespread acceptance among mental health professionals as well as the public, have given rise to a great deal of interest in telemedicine and telepsychiatry. This study tested an Internet-based family intervention for AD that relatives can access from their homes with ease, and at no cost. In addition to improving patient outcomes through instruction of effective behavioral management, we proposed that participation in an Internet program would also reduce caregiver depression and burden. Fifty-three veterans with a clinical diagnosis of AD and their caregiver/relatives were randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for 6 months. We hypothesized that, at the end of the active intervention, participation in the intensive intervention would result reduced patient problematic behavior, caregiver burden, depression, and negative responses to problematic patient behaviors, as well as improved patient medication compliance. At 12 month follow-up, we hypothesized access to the online program would result in more patients remaining at home. The overriding longterm project objective was to develop an effective online education and support program for caregivers of patients with AD that can be manualized, replicated, and disseminated to other clinical and research centers, within both the VA health care system and the community, to enhance the efficiency and effectiveness of psychosocial treatment in AD.
Interventions
BEHAVIORALcaregiver website support
caregiver access to website support for 6 months embedded in one year of customary care
BEHAVIORALcaregiver brief supportive phone calls
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patient living in community and ambulatory * Patient has diagnosis of Alzheimer's disease * Patient age 50-95 * Caregiver age 18-90 * Patient currently under treatment for Alzheimer's disease * Patient and caregiver reside within 2 hours of Los Angeles * Caregiver has home internet access * Patient has close contact with caregiver
Exclusion criteria
* Patient lives in residential setting * No family contact * Acute illness or chronic disease in patient or caregiver * Patient or caregiver plans to leave area within the year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden From Baseline | baseline to end-of-treatment (6 months) | 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. |
| Change in Frequency of Patient Problematic Behavioral Patterns From Baseline | baseline to end of treatment (6 months) | 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. |
| Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline | baseline to end of treatment (6 months) | 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. |
| Change in Caregiver Depression From Baseline | baseline to end-of-treatment (6 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Report of Patient Medication Adherence From Baseline | baseline to end-of-treatment (6 months) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline | baseline to end-of-follow-up (12 months from baseline) | Frequency count of individuals placed in assisted living or nursing homes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caregiver Website relative access to website support for 6 months embedded in one year of customary care | 29 |
| Caregiver Phone Calls relative supportive telephone calls for six months embedded in one year customary care | 24 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 4 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Caregiver Website | Caregiver Phone Calls | Total |
|---|---|---|---|
| Age, Continuous | 78.69 years STANDARD_DEVIATION 9.09 | 81.4 years STANDARD_DEVIATION 6.6 | 79.92 years STANDARD_DEVIATION 8.21 |
| Race/Ethnicity, Customized African-American | 6 patient participants | 4 patient participants | 10 patient participants |
| Race/Ethnicity, Customized Caucasian | 20 patient participants | 19 patient participants | 39 patient participants |
| Race/Ethnicity, Customized Hispanic | 1 patient participants | 1 patient participants | 2 patient participants |
| Race/Ethnicity, Customized Unknown | 2 patient participants | 0 patient participants | 2 patient participants |
| Region of Enrollment United States | 29 participants | 24 participants | 53 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 24 |
| serious Total, serious adverse events | 4 / 29 | 5 / 24 |
Outcome results
Primary
Change in Caregiver Burden From Baseline
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.
Time frame: 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)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Website | Change in Caregiver Burden From Baseline | baseline | 32.04 units on a scale | Standard Error 1.95 |
| Caregiver Website | Change in Caregiver Burden From Baseline | end of treatment | 32.52 units on a scale | Standard Error 2.13 |
| Caregiver Phone Calls | Change in Caregiver Burden From Baseline | baseline | 28.59 units on a scale | Standard Error 2.01 |
| Caregiver Phone Calls | Change in Caregiver Burden From Baseline | end of treatment | 27.55 units on a scale | Standard Error 2.19 |
Comparison: intent to treat analysisp-value: 0.51Mixed Models Analysis
Primary
Change in Caregiver Depression From Baseline
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
Time frame: 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)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Website | Change in Caregiver Depression From Baseline | baseline | 9.27 units on a scale | Standard Error 1.54 |
| Caregiver Website | Change in Caregiver Depression From Baseline | end of treatment | 8.61 units on a scale | Standard Error 1.73 |
| Caregiver Phone Calls | Change in Caregiver Depression From Baseline | baseline | 9.20 units on a scale | Standard Error 1.63 |
| Caregiver Phone Calls | Change in Caregiver Depression From Baseline | end of treatment | 9.43 units on a scale | Standard Error 1.83 |
Comparison: intent to treat analysisp-value: 0.67Mixed Models Analysis
Primary
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
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.
Time frame: 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)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Website | Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline | baseline | 16.04 units on a scale | Standard Error 3 |
| Caregiver Website | 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 |
| Caregiver Phone Calls | Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline | baseline | 19.09 units on a scale | Standard Error 3.08 |
| Caregiver Phone Calls | Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline | end-of-treatment (6 months) | 20.08 units on a scale | Standard Error 3.57 |
Comparison: intent to treat analysisp-value: 0.49Mixed Models Analysis
Primary
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
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.
Time frame: 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)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Website | Change in Frequency of Patient Problematic Behavioral Patterns From Baseline | baseline | 30.69 units on a scale | Standard Error 2.89 |
| Caregiver Website | 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 |
| Caregiver Phone Calls | Change in Frequency of Patient Problematic Behavioral Patterns From Baseline | baseline | 33.04 units on a scale | Standard Error 2.99 |
| Caregiver Phone Calls | Change in Frequency of Patient Problematic Behavioral Patterns From Baseline | end-of-treatment (6 months) | 34.75 units on a scale | Standard Error 3.27 |
Comparison: intent to treat analysisp-value: 0.79Mixed Models Analysis
Secondary
Change in Caregiver Report of Patient Medication Adherence From Baseline
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.
Time frame: baseline to end-of-treatment (6 months)
Population: measure was added to study while in process
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Website | Change in Caregiver Report of Patient Medication Adherence From Baseline | at baseline | 4.63 units on a 1-5 scale | Standard Error 0.47 |
| Caregiver Website | Change in Caregiver Report of Patient Medication Adherence From Baseline | at 6 months | 5.08 units on a 1-5 scale | Standard Error 0.75 |
| Caregiver Phone Calls | Change in Caregiver Report of Patient Medication Adherence From Baseline | at baseline | 4.06 units on a 1-5 scale | Standard Error 0.42 |
| Caregiver Phone Calls | Change in Caregiver Report of Patient Medication Adherence From Baseline | at 6 months | 3.94 units on a 1-5 scale | Standard Error 0.44 |
Comparison: intent to treatp-value: 0.65Mixed Models Analysis
Other Pre-specified
Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline
Frequency count of individuals placed in assisted living or nursing homes
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caregiver Website | Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline | 2 participants |
| Caregiver Phone Calls | Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline | 3 participants |
p-value: 0.64Fisher Exact