| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain Stress Psychological Healthy Rheumatoid Arthritis | Behavioral: Wellness Element 1 - Exercise Behavioral: Wellness Element 2 - Mindfulness Behavioral: Wellness Element 3 - Sleep Hygiene Behavioral: Wellness Element 4 - Social Connectedness Behavioral: Wellness Element 5 - Nutrition Behavioral: Wellness Element 6 - Wellness Exercises Behavioral: Wellness Element 7 - Motivational Messages | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA) |
| Actual Study Start Date : | June 17, 2019 |
| Actual Primary Completion Date : | March 12, 2020 |
| Actual Study Completion Date : | March 12, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Wellness Intervention
KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
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Behavioral: Wellness Element 1 - Exercise
Daily wellness element focusing on Exercise; adherence documented online daily
Behavioral: Wellness Element 2 - Mindfulness Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
Behavioral: Wellness Element 3 - Sleep Hygiene Daily wellness element focusing on sleep hygiene; adherence documented online daily
Behavioral: Wellness Element 4 - Social Connectedness Daily wellness element focusing on Social Connectedness; adherence documented online daily
Behavioral: Wellness Element 5 - Nutrition Daily wellness element focusing on Nutrition; adherence documented online daily
Behavioral: Wellness Element 6 - Wellness Exercises Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
Behavioral: Wellness Element 7 - Motivational Messages Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| United States, Texas | |
| University of Texas at Austin | |
| Austin, Texas, United States, 78701 | |
| Principal Investigator: | Saundra M Jain, PsyD, LPC | University of Texas at Austin |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 18, 2019 | ||||
| First Posted Date ICMJE | June 20, 2019 | ||||
| Last Update Posted Date | April 17, 2020 | ||||
| Actual Study Start Date ICMJE | June 17, 2019 | ||||
| Actual Primary Completion Date | March 12, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA) | ||||
| Official Title ICMJE | KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA) | ||||
| 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. | ||||
| Detailed Description |
It is expected that this 30-day integrated, prescriptive, and trackable wellness intervention (combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition) will be found to be an efficacious program for those with Rheumatoid Arthritis taking a biologic or a JAK inhibitor. Traditionally mental health and other specialties like rheumatology have focused primarily on the diagnosis and treatment of illness rather than incorporating wellness as an essential element of treatment. Those in the helping professions are trained to diagnose health problems with treatment typically focusing on symptom reduction. More recently, mental health and other healthcare specialties like rheumatology have initiated a conversation and subsequent research focusing on the importance of integrating elements of wellness into treatment. Rather than focusing solely on symptom reduction, some providers have begun incorporating elements of wellness promotion into treatment with favorable results. To the best of our knowledge, even though there is abundant research supporting each of the KickStart30 elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements specific to a cohort of patients with RA. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a community-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving public health. The recruitment period will be open for 12 months to obtain a maximum of 50 participants. The study population will be individuals, ages 18 and older, interested in improving their overall wellness and that self-identify as having Rheumatoid Arthritis and taking a biologic or a JAK inhibitor. Each participant will be engaged in the program for 30 days. To determine a participant's eligibility, study personnel will conduct a preliminary screening/orientation telephone interview. If the participant is determined to be eligible for the study based on the preliminary screening/orientation phone interview, study personnel will collect the participant's email address, physical mailing address, and assign the participant a unique identification code based on the order in which the participant was screened. The consent form outlines the purpose and design of the study, data to be collected, confidentiality standards, alternatives to participation, and contact information for research personnel. Participants will have the option to download a PDF of their signed consent form for their records at the time of signing/completion. Study personnel will mail each participant a KickStart30 Workbook within one day of emailing participants their unique identification codes. Participants will be instructed to document adherence of their daily wellness practices and their daily HERO exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the KickStart30 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form at their convenience throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality. Participants will also receive daily motivational emails from MailChimp, which will provide general information about one of the five wellness elements and/or one of the HERO wellness traits, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns. Data capture will occur at two points: once prior to beginning the study and again at the end of the 30-day study. Data will be collected online through program forms; all data will be hosted on Qualtrics, an online survey software. Program Forms assess items including depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, pain, disability, physical function, happiness, enthusiasm, resilience, and optimism in patients with RA. Descriptive statistics will be used to discuss pre- and post-intervention scores. Differences between pretest and 30-day measures will be assessed with repeated measures ANOVA, with a p value of less than 0.05 indicating statistical significance. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Wellness Intervention
KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
13 | ||||
| Original Estimated Enrollment ICMJE |
50 | ||||
| Actual Study Completion Date ICMJE | March 12, 2020 | ||||
| Actual Primary Completion Date | March 12, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03993548 | ||||
| Other Study ID Numbers ICMJE | 2018-10-0095 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Saundra Jain, University of Texas at Austin | ||||
| Study Sponsor ICMJE | University of Texas at Austin | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Texas at Austin | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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