- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249139
Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD (Compass4Care)
Caring4Caregivers: A Theory-driven Mobile Solution to Promote Self-care and Well-being Among Caregivers of Individuals With Alzheimer's and Related Dementias
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The efficacy of the Compass for Care intervention is being tested in a randomized trial involving 254 caregivers caring for a family member or friend with Alzheimer's disease or a related dementia (ADRD). Caregivers who meet study inclusion criteria (e.g., being an ADRD caregiver caring for a family member or friend for 8+ hours/week, residing in the US, agreeing to receive daily text or email messages for three months, not indicating suicidal ideation, and experiencing a level of caregiver burden) as assessed in on online screening survey, are invited to participate in the study.
Caregivers are randomly assigned to either the treatment or attention control condition. The treatment group is provided access to the 12-week Compass for Care mobile first program and attention control group is provided access to a 12-week mobile optimized intervention focused on safety behaviors. Both interventions are delivered in weekly modules and include daily messages delivered by email or text message.
Follow-up assessments are conducted online at 3, 6, and 9 months. Outcomes include caregiver burden, depression, perceived stress, emotional and physical health, life satisfaction, resilience, and well-being. Study protocols include best practices for maximizing retention at follow-up in research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kerry E Evers, PhD
- Phone Number: 401-360-2985
- Email: kevers@prochange.com
Study Contact Backup
- Name: Deborah F Van Marter, MPH
- Phone Number: 401-360-2981
- Email: dvanmarter@prochange.com
Study Locations
-
-
Rhode Island
-
Narragansett, Rhode Island, United States, 02882
- Recruiting
- Pro-Change Behavior Systems
-
Contact:
- Kerry E Evers, PhD
- Phone Number: 401-360-2985
- Email: kevers@prochange.com
-
Contact:
- Deborah F Van Marter, MPH
- Phone Number: 401-360-2981
- Email: dvanmarter@prochange.com
-
Principal Investigator:
- Kerry E Evers, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to read and speak English
- Aged 18+
- Residing in the U.S.
- Regularly use the internet
- Agree to receive daily messages by email or text during the 3-month intervention period
- Currently providing at least 8 hours of unpaid care to a family member or friend diagnosed with Alzheimer's disease, Lewy body dementia, frontotemporal dementia, vascular dementia, dementia type not specified, or mixed dementia
- Have been providing care for at least 3 months;
- Score of 3 or higher on the Zarit burden item (Overall, how burdened do you feel in caring for your relative) OR a score of 2 on this item and a score of 2+ on the PHQ-2 assessment (i.e., Little interest or pleasure in doing things; Feeling down, depressed, or hopeless)
- Expecting to provide care to their family member or friend for at least three more months, or don't know how much longer they will be providing care
Exclusion Criteria:
1. Indicating suicidal ideation based upon the PHQ-9 suicidality ideation item (i.e., Thoughts that you would be better off dead, or of hurting yourself)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Compass for Care (Well-being intervention)
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email.
The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
Participants receive 12 weekly modules containing interactive activities and static content and tailored messages delivered via text message or email.
The intervention focuses on five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.
|
Active Comparator: Compass for Care (Safety intervention)
Participants receive 12 weekly modules and tailored messages delivered via text message or email.
The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
Participants receive 12 weekly modules and tailored messages delivered via text message or email.
The intervention focuses on safety behaviors (e.g., weather safety, first aid, home safety, etc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Zarit Burden Interview (ZBI)
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
Developed from the 29 and 22-item versions, this shortened 12-item Zarit Burden Interview measure assesses subjective burden among caregivers of individuals with dementia.
Caregivers are asked to rate items (e.g., Do you feel… that your health has suffered because of your involvement with your relative?) on a 5-point scale with 0 = never to 4 = nearly always.
Cronbach's alpha is .88.
|
Baseline, 3, 6, and 9 months' follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionaire (PHQ-9)
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
Depression is being assessed using the PHQ-9, which asks the number of days in the past two weeks the respondent had experienced each of the Diagnostic and Statistical Manual (DSM) symptoms of depression, minus suicidality.
Response options are 0 = Not at all, 1 = Several days, 2 = More than half the days, and 3 = Nearly every day.
Scores are summed to produce a total score, and a PHQ-9 cutpoint ≥ 10 is used to define moderate to severe depression.
Both depression symptoms (i.e., total score) and prevalence of current depression (score > 10) will be examined in this study.
|
Baseline, 3, 6, and 9 months' follow-up
|
Resilience Evaluation Measure (REM-3)
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
Developed by ProChange, this 3-item survey assesses three key drivers of resilience: mindset, meaning, and social connections.
Items are rated on a 5-point scale with 1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = almost always.
Cronbach's alpha is .81.
|
Baseline, 3, 6, and 9 months' follow-up
|
World Health Organization Well-Being Index (WHO-5)
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
The WHO-5 is a widely used measure that assesses well-being.
Respondents are asked to rate five items (e.g., I have felt calm and relaxed) in relation to how they've felt over the last two weeks.
Responses range on a 6-point scale from 0=At no time to 5=All of the time.
|
Baseline, 3, 6, and 9 months' follow-up
|
Cohen's Perceived Stress
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
Originally developed in 1983, the Perceived Stress Scale (PSS) includes 10 items (e.g., In the last month, how often have you felt that you were unable to control the important things in your life) focused on varied situations.
Respondents rate the items on a 5-point scale ranging from 0 = never to 4 = very often.
|
Baseline, 3, 6, and 9 months' follow-up
|
Perceived Change Index
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
This measure of well-being assesses factors associated with increased risk for adverse emotional and physical outcomes among caregivers.
Caregivers are asked to rate 13 items (e.g., ability to manage day to day) on a 5- point scale with 1 = became much worse to 5 = improved a lot over the past month.
Negatively worded items are reversed scored and an overall measure mean is computed.
Cronbach's alpha is .88.
|
Baseline, 3, 6, and 9 months' follow-up
|
Cantril/Gallup Life Evaluation Index
Time Frame: Baseline, 3, 6, and 9 months' follow-up
|
In its World Poll administered in 150 countries, Gallup, Inc. uses the 2-item Cantril Self-Anchoring Scale and a simple scoring algorithm to assess subjective well-being.
Respondents are asked to rate their current life-and then to rate their future life, "say about five years from now"-on a ladder where 0 represents the worst possible life and 10 best possible life.
Individuals who rate their current life a "7" or higher AND their future life an "8" or higher are classified as "thriving."
Individuals who rate their current and future lives a "4" or lower are classified as "suffering."
All others are "struggling."
Previous research has shown that those classified as thriving experience less depressive symptoms, higher physical and emotional health and have fewer health risk behaviors than those in struggling and suffering.
|
Baseline, 3, 6, and 9 months' follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kerry E Evers, PhD, Pro-Change Behavior Systems
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R44AG076345 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Compass for Care (Well-being intervention)
-
Christine Kaiser, LAc, DACMRecruiting
-
Louis BhererMitacs; Université de Montréal; Fonds de la Recherche en Santé du QuébecNot yet recruitingAging | Atrial Fibrillation RecurrentCanada
-
Groupe Hospitalier du HavreCompletedHealthy Lifestyle | Students WellbeingFrance
-
Columbia UniversityCompletedPoor Quality SleepUnited States
-
University GhentLiantisRecruiting
-
University of PennsylvaniaCompletedAnxiety | Depressive Symptoms | Affect | Well-BeingUnited States
-
Chiara RafanelliCompletedDiabetes Mellitus, Type 2 | Overweight and ObesityItaly
-
Chinese University of Hong KongCompletedMental Health Wellness 1 | Mental Well-being | Mental Health IssueHong Kong
-
University of PennsylvaniaPennsylvania Department of HealthActive, not recruitingWell-being | Satisfaction | Depression, AnxietyUnited States