Digital Wellness Modules for Quality of Life

Overseen By David Klemanski, Psy.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Heart disease, Arthritis, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on digital wellness modules and does not mention medication changes.

What data supports the effectiveness of the Caravan Wellness app treatment?

Research shows that digital health programs, like the Caravan Wellness app, can offer psychological and physical health benefits, with high user satisfaction and engagement, especially among older adults. However, the overall evidence of clinical benefit for most health apps is limited, with consistent benefits mainly seen in diabetes management. ^{1 2 3 4 5}

How does the Caravan Wellness app treatment differ from other treatments for improving quality of life?

The Caravan Wellness app is unique because it acts like a personal trainer by gathering personal data and providing tailored recommendations to improve well-being, unlike traditional treatments that may not offer personalized feedback or motivation. It also monitors progress over time, offering incentives to help users achieve their wellness goals, which is a novel approach compared to standard treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Research Team

David Klemanski, Psy.D., MPH

Principal Investigator

Yale University

Eligibility Criteria

This trial is for U.S. residents who are generally healthy and not currently experiencing significant depression, anxiety, psychosis, mania, or severe physical health issues that would limit light to moderate exercise.

Inclusion Criteria

Resides in United States

Exclusion Criteria

Positive Psychiatric Disorders Screening Questions: Positive screen for depression, excluding suicide (PHQ-8) cutoff score > 6, positive screen for panic (SMPD) cutoff score > 2, positive screen for generalized anxiety (GAD-7) cutoff score > 10, positive screen psychosis (PDSQ) via psychosis section, cutoff score > 3, positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score > 6

I have health issues that may prevent me from doing light to moderate exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in digital wellness modules, including mindfulness and light to moderate physical activity, using the Caravan Wellness App

3 weeks

Virtual participation

Follow-up

Participants are monitored for changes in stress, anxiety, depression, mindfulness, and quality of life

3 months

Virtual assessments at 1 month and 3 months

Treatment Details

Interventions

• Caravan Wellness app

Trial Overview The study tests the Caravan Wellness app's digital wellness modules on improving quality of life. It focuses on mindfulness and physical exercises' effects on motivation for health behavior change and emotional well-being over time.

Participant Groups

Group I: Mindfulness Experimental Treatment 1 Intervention

Participants will take part in 7 repeating digital mindfulness modules using the Caravan Wellness App.

Group II: Light to Moderate Physical Activity Experimental Treatment 1 Intervention

Participants will take part in 7 repeating light to moderate physical activity digital wellness modules using the Caravan Wellness App.

Group III: Control Active Control 1 Intervention

A no intervention group that will not be using the Caravan Wellness App.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Caravan Wellness

Collaborator

Trials

1

Recruited

120+

Findings from Research

Smartphone health apps show consistent clinical benefits primarily for diabetes management, evidenced by reduced HbA1c levels, while benefits for other chronic diseases are either absent or marginal.

A proposed evaluation framework identifies 12 design features that enhance usability and efficacy, highlighting the need for standardized assessments to ensure the quality and effectiveness of health apps before endorsement by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Scott, IA., Scuffham, P., Gupta, D., et al.[2020]

Patients using self-management digital interventions (DIs) for chronic conditions like hypertension and asthma reported feeling more reassured and engaged in their health management, leading to more meaningful consultations with healthcare professionals (HCPs).

Healthcare professionals noted improved clinical control and appreciated patients' enhanced understanding of their conditions, indicating that DIs can effectively support both patient self-management and HCP oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. Morton, K., Dennison, L., May, C., et al.[2022]

A study involving 140 older adults (median age 59.82) showed that a digital wellness program was highly engaging, with over 65% of participants completing at least one task each month over 17 weeks.

Participants reported high satisfaction with the program, achieving a Net Promoter Score (NPS) of 43 after 30 days, and experienced an average weight loss of 3.44 pounds in the first month, indicating potential health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Adoption of a Focused Digital Wellness Program in Older Adults. Tam, E., Boas, PKV., Ruaro, F., et al.[2021]

A review of 6 systematic reviews identified only 22 stand-alone mobile health apps that have been evaluated in randomized controlled trials (RCTs), primarily focusing on diabetes, mental health, and obesity.

While 11 out of 23 trials showed meaningful health benefits from these apps, the overall quality of evidence was low due to small sample sizes and high risk of bias, indicating a need for more rigorous studies before these apps can be widely prescribed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. Byambasuren, O., Sanders, S., Beller, E., et al.[2020]

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.

Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. Fu, H., McMahon, SK., Gross, CR., et al.[2022]

The Wellness App developed in the Smart Health 2.0 project serves as a personal trainer, providing tailored recommendations based on users' physical parameters and lifestyle to enhance well-being.

A pilot study in Calabria showed high usability (average score of 77.16) and navigability (average score of 76.87) of the app, along with significant improvements in users' Wellness Index (95% significance) and Mediterranean Adequacy Index (99% significance).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wellness Mobile Application for Smart Health: Pilot Study Design and Results. Sannino, G., Forastiere, M., De Pietro, G.[2018]

A new mobile application framework has been developed to facilitate the rapid and cost-effective creation of health and wellness applications, demonstrated through a Tele-ECG use case.

The platform supports interoperability with clinical document standards like HL7 CDA, enabling seamless connectivity between healthcare professionals, patients, and medical devices, which enhances the sharing and management of health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health and wellness application framework. Laakko, T., Leppänen, J., Lähteenmäki, J., et al.[2019]

The Nuadu Concept is an innovative wellness toolbox that uses Information and Communication Technologies (ICT) to help individuals manage health risks related to lifestyle choices, such as poor diet and inactivity.

By empowering users to select personalized tools based on psychological models for behavior change, the Nuadu Concept aims to make wellness management more efficient, accessible, and affordable for a wide audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nuadu concept for personal management of lifestyle related health risks. Mattila, E., Korhonen, I., Lappalainen, R., et al.[2020]

A pilot project in an assisted living facility is using various technologies, such as telehealth and cognitive assessment software, to assess multiple aspects of wellness in older adults over an eight-week period.

Preliminary results show that older adults are open to using technology for wellness assessments when provided with proper training, suggesting that informatics can enhance healthcare and support holistic wellness evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using informatics to capture older adults' wellness. Demiris, G., Thompson, HJ., Reeder, B., et al.[2021]

The Wellness Diary (WD) is a mobile wellness management tool based on Cognitive-Behavioral Therapy (CBT) that was well accepted by users in two 3-month studies focused on weight management and general wellness.

Participants consistently used the WD, averaging over 5 entries per day, indicating its effectiveness and usability in supporting healthier lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile diary for wellness management--results on usage and usability in two user studies. Mattila, E., Pärkkä, J., Hermersdorf, M., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Adoption of a Focused Digital Wellness Program in Older Adults. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Wellness Mobile Application for Smart Health: Pilot Study Design and Results. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Mobile health and wellness application framework. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Nuadu concept for personal management of lifestyle related health risks. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Using informatics to capture older adults' wellness. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Mobile diary for wellness management--results on usage and usability in two user studies. [2022]