KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA)
KickStart30
1 other identifier
interventional
13
1 country
1
Brief Summary
This study explores the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of patients with Rheumatoid Arthritis (RA) taking a biologic. This 30-day wellness intervention (called "KickStart30") combines five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition. Additionally, the program requires that participants implement 5 wellness interventions daily for the 30-day study, document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and optimism) exercises to improve mental wellness, and complete online program forms before and after the 30-day intervention. Participants are assessed pre- and post-intervention to determine whether the intervention promotes wellness behavior changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Jun 2019
Shorter than P25 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2020
CompletedApril 17, 2020
March 1, 2020
9 months
June 18, 2019
April 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Change in Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a nine-item depression self-report questionnaire for screening and measurement of severity of major depression. Scores range from 0-27 (Lower scores = Less depression).
0, and 30 days
Change in Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a seven-item self-report questionnaire for screening and measurement of severity of generalized anxiety disorder. Scores range from 0-21 (Lower scores = Less anxiety).
0, and 30 days
Change in World Health Organization Well-Being Index (WHO-5)
The WHO-5 Well-Being Index is a five-item self-report questionnaire covering 5 areas: positive mood, vitality, and general interests. Scores range from 0-25 (Higher scores = Higher levels of well-being).
0, and 30 days
Change in Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Scores range from 15-90 (Higher scores = Higher levels of mindfulness).
0, and 30 days
Change in Sleep Condition Indicator (SCI)
The SCI is a brief 8-item screening tool to evaluate insomnia disorder. Scores range from 0-32 (Lower scores = Greater sleep problems).
0, and 30 days
Change in Social Connectedness Scale (SCS)
The SCS is an 8-item questionnaire that assesses the degree to which people feel connected to others in their social environment. Scores range from 8 to 48. (Higher scores = More connectedness to others).
0, and 30 days
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
The EADES is a 24-item sub-scale used to measure stress-related eating. Scores range from 24-120 (Lower scores = Greater emotion and stress-related eating).
0, and 30 days
Change in Brief Pain Inventory (BPI)
The BPI is an 8-item scale that assesses pain. Scores range from 0-10. (0 = No pain and 10 = Pain as bad as you can imagine).
0, and 30 days
Change in Sheehan Disability Scale (SDS)
The SDS is a 3-item measurement tool for assessing functional impairment in three inter-related domains: work/school, social, and family life. Scores range from 0-10 (Higher scores = Higher levels of functional impairment).
0, and 30 days
Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
The CPFQ is a brief 7-item scale designed to assess cognitive and physical functioning. Scores range from 7-42 (Lower scores = Higher levels of cognitive and physical functioning).
0, and 30 days
Change in HERO Wellness Scale
The HERO Wellness Scale is a brief 5-item scale designed to measure four wellness traits plus perceived mental wellness. Scores range from 0-50 (Lower scores = Lower levels of mental wellness).
0, and 30 days
Post-Program Participant Questionnaire
A brief 6 question post study survey that captures participants' opinions about KickStart30.
0, and 30 days
Change in Health Assessment Questionnaire-II (HAQ-II)
The HAQ-II is a ten-item self-report questionnaire for assessing functional status in individuals with rheumatic disease. Scores range from 0-3.0 (Higher scores = Worse functioning and greater disability).
0, and 30 days
Study Arms (1)
Wellness Intervention
EXPERIMENTALKickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Interventions
Daily wellness element focusing on Exercise; adherence documented online daily
Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
Daily wellness element focusing on sleep hygiene; adherence documented online daily
Daily wellness element focusing on Social Connectedness; adherence documented online daily
Daily wellness element focusing on Nutrition; adherence documented online daily
Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
Eligibility Criteria
You may qualify if:
- Diagnosed with Rheumatoid Arthritis (RA) by a Rheumatologist
- Currently taking a biologic and/or a JaK inhibitor for the treatment of RA, including one or more of the following: Orencia (intravenous infusion or subcutaneous injection), Humira (subcutaneous injection), Kineret (subcutaneous injection), Cimzia (subcutaneous injection), Enbrel (subcutaneous injection), Simponi (subcutaneous injection), Simponi Aria (intravenous infusion), Remicade (intravenous infusion), Kevzara (subcutaneous injection), Rituxan (intravenous infusion), Actemra (intravenous infusion or subcutaneous injection), Olumiant (oral administration), Xeljanz (oral administration)
- Interested in improving overall wellness
- Not pregnant and no plans to get pregnant during the 30-day study
- English-speaking
- Must have access to a reliable Internet-enabled computer
- Must possess basic computer skills
You may not qualify if:
- Has not been diagnosed with RA by a Rheumatologist
- Not currently taking a biologic or a JAK inhibitor for the treatment of RA
- Not interested in improving overall wellness
- Pregnant or plans to get pregnant during the 30-day study
- Does not speak English
- Does not have access to a reliable, Internet-enabled computer
- Reports a lack of basic computer skills
- Acutely suicidal and/or actively psychotic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at Austin
Austin, Texas, 78701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saundra M Jain, PsyD, LPC
University of Texas at Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Clinical Affiliate, School of Nursing
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 20, 2019
Study Start
June 17, 2019
Primary Completion
March 12, 2020
Study Completion
March 12, 2020
Last Updated
April 17, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share