Fun For Wellness: Online Well-Being Promotion Intervention in a Patient Sample

NCT03060213 | Completed

• 1 other identifier: 20170001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Subjective well-being refers to people's level of satisfaction with life as a whole and with multiple dimensions within it. Interventions that promote subjective well-being are important because there is evidence that physical health, mental health, substance use and health care costs may be related to subjective well-being. This randomized controlled trial will evaluate an online intervention, named Fun For Wellness (FFW), designed to promote well-being skills and self-efficacy in six domains of life: interpersonal, community, occupational, physical, psychological, and economic (I COPPE). The Usual Care (UC) control group will be wait-listed. Five hundred (500) community-based adult patient participants will be enrolled. We hypothesize that compared to the UC group, intervention group participants will show greater improvement in their overall subjective well-being, domain-specific well-being, health-related quality of life, and well-being self-efficacy.

Conditions

Health Promotion

Keywords

Well-Being; e-Health; Randomized Controlled Trial; Self-Efficacy; Interpersonal well-being; Community well-being; Occupational well-being; Physical well-being; Psychological well-being; Economic well-being

Outcome Measures

Primary Outcomes (7)

• Change in overall well-being I COPPE Scale scores between baseline and time 3.

  The primary objective of this study is to determine if FFW improves well-being as measured by change in I COPPE Scale domain scores after 60 days compared to usual care for patient well-being at the University of Miami's UHealth Lennar Medical Center. The investigators will assess the efficacy of FFW on I COPPE overall well-being as measured by the I COPPE Scale overall well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in interpersonal well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving interpersonal well-being as measured by the I COPPE Scale interpersonal well-being score

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in community well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving community well-being as measured by the I COPPE Scale community well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in occupational well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving occupational well-being as measured by the I COPPE Scale occupational well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in physical well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving physical well-being as measured by the I COPPE Scale physical well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in psychological well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving psychological well-being as measured by the I COPPE Scale psychological well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

• Change in economic well-being I COPPE Scale score between baseline and time 3.

  The investigators will assess the efficacy of FFW on improving economic well-being as measured by the I COPPE Scale economic well-being score.

  baseline (time 1), 30 days (time 2), and 60 days (time 3)

Secondary Outcomes (21)

• Change in health-related quality of life (HRQOL)-physical component score between baseline and time 3.

  baseline, 30 days, and 60 days

• Change in self-efficacy in well-being (SEWB) overall domain score between baseline and time 3.

  baseline, 30 days, and 60 days

• Change in self-efficacy in well-being (SEWB) interpersonal domain score between baseline and time 3.

  baseline, 30 days, and 60 days

• Change in self-efficacy in well-being (SEWB) community domain score between baseline and time 3.

  baseline, 30 days, and 60 days

• Change in self-efficacy in well-being (SEWB) occupational domain score between baseline and time 3.

  baseline, 30 days, and 60 days

Other Outcomes (2)

• Change in I COPPE actions total score between baseline and time 3.

  baseline, 30 days, and 60 days

• Strength of the relationship between self-efficacy to comply scores and complier average causal effect (CACE) values over time.

  baseline, 30 days, and 60 days

Study Arms (2)

Fun For Wellness (FFW)

EXPERIMENTAL

Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being.

Behavioral: Fun For Wellness (FFW)

Usual Care (UC)

NO INTERVENTION

The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period.

Interventions

Fun For Wellness (FFW) BEHAVIORAL

FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.

Fun For Wellness (FFW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is at least 18 years old
• Individual is a current patient at University of Miami's UHealth Lennar Medical Center
• Individual is not now, nor has ever participated in activities of the Fun For Wellness online program

You may not qualify if:

• Individual less than 18 years old
• Individuals who are not current a patient at University of Miami's UHealth Lennar Medical Center
• Individual is now, or has ever participated in activities of the Fun For Wellness online program

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

UHealth Lennar Medical Center

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Health

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Isaac Prilleltensky, Ph.D.

  Dean, School of Education and Human Development; Professor; Vice Provost, Office of Institutional Culture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants who have completed the full online T1 battery will be randomly assigned in real-time by the computer to either the intervention condition or the UC control condition. Randomization, group assignment, and assessments will be conducted solely by the computer program, so researchers will be blind to participant randomization, group assignment, and participant group identity during assessment times. With regard to group size and power, experience from our prior efficacy study of FFW indicates that for the current study, the computer program will use a 2:1 randomization algorithm so that there are twice as many FFW intervention participants as UC control participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the School of Education and Human Development; Professor; Vice Provost for Institutional Culture

Model Details: The intervention group will be compared to a usual care (UC) control group on outcomes of overall subjective well-being, domain-specific well-being, health-related quality of life, and well-being self-efficacy. The intervention group will participate in online activities for 30 days while UC control group participants will be asked to conduct their lives as usual for the same 30 day period. Both groups will complete assessments during this time period. The UC group will be given access to the intervention for 30 days after all study participants have completed the three survey battery administrations.

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: March 6, 2017
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)