Innovative Web-based Service Platform Called Adult Wellbeing CheckUp (AWC) to Assess Older Adults Wellbeing, Obtain Evidence-based Recommendations, and Receive Support to Take Action.

Official title

Adult Wellbeing CheckUp (AWC)

Overview

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

• Behavioral Adult 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 th
• Behavioral General 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.

Primary outcome measures

• Change in Patient Activation Measure (PAM-13) Score [Time frame: Baseline, Week 12, and Week 24]

Secondary outcome measures (12)

• Change in Self-Reported Actions Taken [Time frame: Baseline and Week 24]
• Change in Adult Wellbeing Assessment Score [Time frame: Baseline and Week 24]
• Change in Patient Health Questionnaire-4 (PHQ-4) Score [Time frame: Baseline and Week 24]
• Change in Rapid Assessment of Physical Activity (RAPA) Score [Time frame: Baseline and Week 24]
• Change in UCLA Loneliness Scale-3 Score [Time frame: Baseline and Week 24]
• Change in Lubben Social Network Scale (LSNS-6) Score [Time frame: Baseline and Week 24]
• Change in Duke Sense of Belonging Short Form Score [Time frame: Baseline and Week 24]
• Change in PROMIS Sleep Disturbance Short Form Score [Time frame: Baseline and Week 24]
• Change in Topic-Level Impact Ratings [Time frame: Week 12 and Week 24]
• Change in Global Impact of Actions Score [Time frame: Week 12 and Week 24]
• Reported Barriers to Taking Action [Time frame: Week 12 and Week 24]
• Change in Zarit Burden Interview (ZBI-12) Score [Time frame: Baseline and Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• BellAge Inc.dba BetterAge — Sunnyside

Publications

• Fauth E, Hess K, Piercy K, Norton M, Corcoran C, Rabins P, Lyketsos C, Tschanz J. Caregivers' relationship closeness with the person with dementia predicts both positive and negative outcomes for caregivers' physical health and psychological well-being. Aging Ment Health. 2012;16(6):699-711. doi: 10.1080/13607863.2012.678482. PMID 22548375

Identifiers

NCT: NCT07489170 · 4R44AG082602

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗