Alzheimer Disease, Caregiver Burnout, Dementia
Conditions
Keywords
MobileHealth, Caregiving, Dementia, Alzheimer Disease
Brief summary
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.
Detailed description
Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care. The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.
Interventions
BEHAVIORALCARE-Well App
Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
BEHAVIORALInternet Links
Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
Sponsors
University of Rhode Island
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A full-scale randomized, controlled trial: 20 participants will be randomized to receive a tablet pre-loaded with a list of internet links relevant to dementia caregiving and 20 participants will be randomized to receive a tablet pre-loaded with the CARE-Well App. Both groups will be instructed to use their tablets at least 4 times per week for 3 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adequate English-speaking and reading skills * Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone) * Live in the community (either with the care recipient or without) * Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment. * Report some degree of distress associated with caregiving * Access to Wifi at home
Exclusion criteria
* Major acute medical illness * Severe mental illness (e.g. bipolar, schizophrenia) * Diagnosed cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App Content Satisfaction | 3 months | Percentage of participants satisfied or very satisfied with App content. |
| Timing of Assessments | 3 months | Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study. |
| Completion Rates | 3 months | Percentage of participants who completed the intervention. |
| Interest in Continuation of Tablet/App Use After Formal Trial | 3 months | Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability. |
| App Technology Satisfaction | 3 months | Percentage of participants satisfied or very satisfied with App technology. |
| Randomization | 3 months | Percentage of participants who decline participation because of randomization. |
| Study Enrollment Rate and Retention | 3 months | Percentage of participants enrolled and who remain enrolled for the duration of the study. |
| Intervention Adherence | 3 months | Percentage of participants who used the internet links or the app for the 3-month intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview | Baseline and immediately Post-Intervention at 3 months | Caregiver burden scale; 0-88 points; higher scores indicate worse outcome. |
| Revised Memory and Behavior Problem Checklist | Baseline and immediately Post-Intervention at 3 months | Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes. |
| Desire to Institutionalize Scale | Baseline and immediately Post-Intervention at 3 months | Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize). |
| Center for Epidemiologic Studies Depression Scale | Baseline and immediately Post-Intervention at 3 months | Depression scale; 0-30 points; higher scores indicate worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Internet Links A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week. | 20 |
| CARE-Well App A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Internet Links | CARE-Well App | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 14 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Continuous | 68.70 years STANDARD_DEVIATION 8.15 | 64.05 years STANDARD_DEVIATION 12.43 | 66.38 years STANDARD_DEVIATION 10.64 |
| Depression | 12.95 units on a scale STANDARD_DEVIATION 8.02 | 13.55 units on a scale STANDARD_DEVIATION 9.69 | 13.25 units on a scale STANDARD_DEVIATION 9.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 20 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 1 Participants | 1 Participants | 2 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 38 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
App Content Satisfaction
Percentage of participants satisfied or very satisfied with App content.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | App Content Satisfaction | 13 Participants |
| CARE-Well App | App Content Satisfaction | 11 Participants |
Primary
App Technology Satisfaction
Percentage of participants satisfied or very satisfied with App technology.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | App Technology Satisfaction | 13 Participants |
| CARE-Well App | App Technology Satisfaction | 12 Participants |
Primary
Completion Rates
Percentage of participants who completed the intervention.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Completion Rates | 18 Participants |
| CARE-Well App | Completion Rates | 16 Participants |
Primary
Interest in Continuation of Tablet/App Use After Formal Trial
Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Interest in Continuation of Tablet/App Use After Formal Trial | 10 Participants |
| CARE-Well App | Interest in Continuation of Tablet/App Use After Formal Trial | 10 Participants |
Primary
Intervention Adherence
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Intervention Adherence | 18 Participants |
| CARE-Well App | Intervention Adherence | 16 Participants |
Primary
Randomization
Percentage of participants who decline participation because of randomization.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Randomization | 0 Participants |
| CARE-Well App | Randomization | 0 Participants |
Primary
Study Enrollment Rate and Retention
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Study Enrollment Rate and Retention | 18 Participants |
| CARE-Well App | Study Enrollment Rate and Retention | 16 Participants |
Primary
Timing of Assessments
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Internet Links | Timing of Assessments | 18 Participants |
| CARE-Well App | Timing of Assessments | 16 Participants |
Secondary
Center for Epidemiologic Studies Depression Scale
Depression scale; 0-30 points; higher scores indicate worse outcome.
Time frame: Baseline and immediately Post-Intervention at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet Links | Center for Epidemiologic Studies Depression Scale | Baseline | 13.29 units on a scale | Standard Deviation 7.88 |
| Internet Links | Center for Epidemiologic Studies Depression Scale | Post-Intervention | 16.71 units on a scale | Standard Deviation 8.36 |
| CARE-Well App | Center for Epidemiologic Studies Depression Scale | Baseline | 13.94 units on a scale | Standard Deviation 12.19 |
| CARE-Well App | Center for Epidemiologic Studies Depression Scale | Post-Intervention | 17.38 units on a scale | Standard Deviation 11.67 |
Secondary
Desire to Institutionalize Scale
Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Time frame: Baseline and immediately Post-Intervention at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet Links | Desire to Institutionalize Scale | Baseline | 0.82 units on a scale | Standard Deviation 1.24 |
| Internet Links | Desire to Institutionalize Scale | Post Intervention | 1.12 units on a scale | Standard Deviation 1.54 |
| CARE-Well App | Desire to Institutionalize Scale | Baseline | 1.38 units on a scale | Standard Deviation 1.45 |
| CARE-Well App | Desire to Institutionalize Scale | Post Intervention | 1.94 units on a scale | Standard Deviation 2.29 |
Secondary
Revised Memory and Behavior Problem Checklist
Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Time frame: Baseline and immediately Post-Intervention at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet Links | Revised Memory and Behavior Problem Checklist | Baseline | 22.88 units on a scale | Standard Deviation 7.9 |
| Internet Links | Revised Memory and Behavior Problem Checklist | Post Intervention | 18.10 units on a scale | Standard Deviation 10.56 |
| CARE-Well App | Revised Memory and Behavior Problem Checklist | Baseline | 22.00 units on a scale | Standard Deviation 8.61 |
| CARE-Well App | Revised Memory and Behavior Problem Checklist | Post Intervention | 11.56 units on a scale | Standard Deviation 16.91 |
Secondary
Zarit Burden Interview
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Time frame: Baseline and immediately Post-Intervention at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet Links | Zarit Burden Interview | Baseline | 55.53 units on a scale | Standard Deviation 9.82 |
| Internet Links | Zarit Burden Interview | Post Intervention | 58.11 units on a scale | Standard Deviation 10.93 |
| CARE-Well App | Zarit Burden Interview | Baseline | 56.56 units on a scale | Standard Deviation 14.4 |
| CARE-Well App | Zarit Burden Interview | Post Intervention | 57.56 units on a scale | Standard Deviation 13.22 |