Control Group, Intervention Group
Conditions
Keywords
Healthy aging, Caregiver wellbeing, Patient activation, Digital health intervention, Older adults
Brief summary
The goal of this clinical trial is to learn whether a web-based program called the Adult Wellbeing CheckUp (AWC) can help older adults improve their wellbeing and take actions to support healthy aging. The study will include adults aged 60 years and older, including both older adults and people who care for someone living with Alzheimer's disease or related dementias. The main questions this study aims to answer are: 1. Does using the Adult Wellbeing CheckUp increase participants' ability to manage their health and wellbeing, measured by the Patient Activation Measure (PAM-13)? 2. Do participants who use the Adult Wellbeing CheckUp take more actions to improve their wellbeing compared with those who do not use the program? Researchers will compare participants who use the AWC platform with participants who receive general healthy aging information to see whether the AWC program leads to greater improvements in wellbeing and health engagement. The AWC platform is an online tool that helps older adults review their wellbeing across several areas of life, such as physical health, mental health, social connections, and daily habits. After completing an online assessment, the platform provides personal action plans and specific recommendations to help participants improve areas where their wellbeing scores are low. About 496 participants aged 60 and older will take part in this study. This group will include both older adults and care partners for people living with Alzheimer's disease or related dementias. Participants will take part in the study for about 24 weeks (6 months). Participants will be randomly assigned (by chance) to one of two groups: 1. Intervention group: Participants will create an account and use the Adult Wellbeing CheckUp platform for 24 weeks. They will complete a wellbeing assessment and receive personal action plans and specific recommendations. They will also receive weekly encouragement messages and personalized check-ins by email or text. 2. Comparison group: Participants will complete the same baseline assessment but will not have access to the AWC platform during the study. Instead, they will receive weekly general healthy aging information by email. All participants will complete surveys at the start of the study, at 12 weeks, and at 24 weeks. These surveys will measure health engagement, wellbeing, and actions taken to improve wellbeing. After the study ends, participants in the comparison group may be offered access to the platform in a future time. Researchers will use the results of this study to learn whether the Adult Wellbeing CheckUp can help older adults take meaningful steps to improve their health and wellbeing.
Interventions
BEHAVIORALAdult Wellbeing CheckUp (AWC)
The Adult Wellbeing CheckUp (AWC) is a web-based wellbeing assessment and recommendation platform designed for older adults and care partners. Participants complete an online assessment of multiple wellbeing domains. The platform uses a rules-based algorithm to generate evidence-based guidance and actionable plans for domains with low scores or areas participants choose to improve. Participants in the intervention arm receive ongoing encouragement messages and check-ins via email or text over the 24-week study period.
BEHAVIORALGeneral Healthy Aging Information
Participants receive weekly non-personalized informational messages about general healthy aging topics delivered by email during the 24-week study period. These messages provide general education but do not include personal recommendations, interactive features, or access to the Adult Wellbeing CheckUp platform.
Sponsors
BellAge Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* older adults aged 60 years or older, * able to speak and write in English, * a PHQ-2 depression screening score of less than 3, * has ability to access the internet, * can demonstrate literacy using online platforms, and * has access to an active email account that they can use to receive study-related communications.
Exclusion criteria
* less than 60 years of age * not able to speak and write in English * a PHQ-2 depression screening score of 3 or greater * not able to access the internet, and * not able to demonstrate literacy using online platforms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation Measure (PAM-13) Score | Baseline, Week 12, and Week 24 | Patient activation measured using the 13-item Patient Activation Measure (PAM-13), a validated survey that assesses participants' knowledge, skills, and confidence for managing their health and wellbeing. Scores range from 0 to 100, with higher scores indicating greater activation. The primary analysis will compare change in PAM-13 scores between intervention and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Actions Taken | Baseline and Week 24 | Participant-reported actions taken to improve wellbeing in prioritized domains based on recommendations provided during the study. Responses are used to assess follow-through on recommended wellbeing actions. |
| Change in Adult Wellbeing Assessment Score | Baseline and Week 24 | Overall wellbeing measured using the Adult Wellbeing Assessment, a 13-item self-report questionnaire designed for older adults. The measure assesses multiple domains of wellbeing, including physical health, mental and emotional wellbeing, social connection, sense of purpose, and daily functioning. Responses are scored to produce an overall wellbeing score, with higher scores indicating better overall wellbeing. |
| Change in Patient Health Questionnaire-4 (PHQ-4) Score | Baseline and Week 24 | Mental health symptoms measured using the Patient Health Questionnaire-4 (PHQ-4), a validated 4-item screening tool assessing anxiety and depression symptoms. Scores range from 0 to 12, with higher scores indicating greater symptom severity. |
| Change in Rapid Assessment of Physical Activity (RAPA) Score | Baseline and Week 24 | Physical activity level measured using the Rapid Assessment of Physical Activity (RAPA). Aerobic activity (RAPA-1) is scored based on the highest numbered activity level endorsed (1-7), classifying participants from sedentary to active. Strength and flexibility activities (RAPA-2) are recorded separately and categorized as none (0), strength only (1), flexibility only (2), or both strength and flexibility activities (3). |
| Change in UCLA Loneliness Scale-3 Score | Baseline and Week 24 | Emotional loneliness measured using the UCLA Loneliness Scale-3, a validated 3-item self-report scale assessing perceived loneliness and social isolation. Scores range from 3 to 9, with higher scores indicating greater loneliness. |
| Change in Lubben Social Network Scale (LSNS-6) Score | Baseline and Week 24 | Social isolation measured using the Lubben Social Network Scale (LSNS-6), a validated 6-item measure assessing perceived social support from family and friends. Scores range from 0 to 30, with higher scores indicating larger and more supportive social networks. |
| Change in Duke Sense of Belonging Short Form Score | Baseline and Week 24 | Sense of belonging and social connectedness measured using two items adapted from the Duke Social Support/Sense of Belonging questionnaire assessing frequency of contact and time spent with friends or family. The first item assesses frequency of contact with friends or family (in person, by phone, or by video) and is scored on a 5-point scale from 1 (rarely or never) to 5 (daily). The second item assesses the number of times participants spend time with someone who does not live with them in a typical week and is scored on a 4-point scale from 1 (none) to 4 (five or more times). Item scores are summed to produce a total score ranging from 2 to 9, with higher scores indicating greater social connectedness and sense of belonging. |
| Change in PROMIS Sleep Disturbance Short Form Score | Baseline and Week 24 | Sleep disturbance measured using the PROMIS Sleep Disturbance Short Form (8a), an 8-item validated self-report questionnaire assessing perceived sleep quality, sleep depth, and difficulty falling or staying asleep over the past seven days. Each item is rated on a 5-point response scale. Responses are summed to produce a raw score ranging from 8 to 40. Higher T-scores indicate greater sleep disturbance. |
| Change in Topic-Level Impact Ratings | Week 12 and Week 24 | Change in perceived impact of actions taken within prioritized wellbeing domains measured using a single-item question. Participants rate the impact of actions taken in specific domains using a numeric rating scale from 0 to 10, where 0 indicates no impact and 10 indicates very high positive impact on wellbeing. Higher scores indicate greater perceived positive impact of actions taken within the selected wellbeing domain. |
| Change in Global Impact of Actions Score | Week 12 and Week 24 | Change in perceived overall impact of actions taken on wellbeing measured using a single-item question. Participants rate the overall impact of actions taken on their wellbeing using a numeric rating scale from 0 to 10, where 0 indicates no impact and 10 indicates very high positive impact on overall wellbeing. Higher scores indicate greater perceived overall benefit from actions taken. |
| Reported Barriers to Taking Action | Week 12 and Week 24 | Participant-reported barriers that may limit engagement with recommended wellbeing actions. Barriers are assessed using a survey question allowing participants to select one or more applicable options from a predefined list (e.g., time constraints, lack of resources, lack of motivation, or other challenges). |
| Change in Zarit Burden Interview (ZBI-12) Score | Baseline and Week 24 | Change in caregiver burden among care partner participants measured using the 12-item Zarit Burden Interview (ZBI-12). Each item is rated on a 5-point Likert scale from 0 (never) to 4 (nearly always). Total scores range from 0 to 48, with higher scores indicating greater caregiver burden. |
Countries
United States
Contacts
CONTACTDiana Yin, M.P.P., M.B.A.
Outcome results
None listed