Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Rhode Island | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet Links | Other | 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. |
|
| CARE-Well App | Experimental | A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARE-Well App | Behavioral | Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Randomization | Percentage of participants who decline participation because of randomization. | 3 months |
| Study Enrollment Rate and Retention | Percentage of participants enrolled and who remain enrolled for the duration of the study. | 3 months |
| Intervention Adherence | Percentage of participants who used the internet links or the app for the 3-month intervention period. | 3 months |
| Timing of Assessments | Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study. | 3 months |
| Completion Rates | Percentage of participants who completed the intervention. | 3 months |
| 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. | 3 months |
| App Technology Satisfaction | Percentage of participants satisfied or very satisfied with App technology. | 3 months |
| App Content Satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale | Depression scale; 0-30 points; higher scores indicate worse outcome. | Baseline and immediately Post-Intervention at 3 months |
| Zarit Burden Interview |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Tremont, PhD | Rhode Island Hospital | Principal Investigator |
| Kunal Mankodiya, PhD | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rhode Island | Kingston | Rhode Island | 02881 | United States | ||
| Rhode Island Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Randomization | Percentage of participants who decline participation because of randomization. | Posted | Count of Participants | Participants | 3 months |
|
3 months for each participant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Tremont | Rhode Island Hospital | 401-444-4500 | gtremont@lifespan.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2020 | Sep 5, 2023 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Internet Links | Behavioral | 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. |
|
Percentage of participants satisfied or very satisfied with App content. |
| 3 months |
Caregiver burden scale; 0-88 points; higher scores indicate worse outcome.
| Baseline and immediately Post-Intervention at 3 months |
| Revised Memory and Behavior Problem Checklist | Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes. | Baseline and immediately Post-Intervention at 3 months |
| Desire to Institutionalize Scale | Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize). | Baseline and immediately Post-Intervention at 3 months |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Depression | Center for Epidemiologic Studies- Depression Scale; scores range from 0-30; higher scores reflect greater depression | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Study Enrollment Rate and Retention | Percentage of participants enrolled and who remain enrolled for the duration of the study. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Intervention Adherence | Percentage of participants who used the internet links or the app for the 3-month intervention period. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Completion Rates | Percentage of participants who completed the intervention. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | App Technology Satisfaction | Percentage of participants satisfied or very satisfied with App technology. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | App Content Satisfaction | Percentage of participants satisfied or very satisfied with App content. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale | Depression scale; 0-30 points; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediately Post-Intervention at 3 months |
|
|
|
| Secondary | Zarit Burden Interview | Caregiver burden scale; 0-88 points; higher scores indicate worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediately Post-Intervention at 3 months |
|
|
|
| Secondary | Revised Memory and Behavior Problem Checklist | Caregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediately Post-Intervention at 3 months |
|
|
|
| Secondary | Desire to Institutionalize Scale | Caregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize). | Posted | Mean | Standard Deviation | units on a scale | Baseline and immediately Post-Intervention at 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |