Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Servings of Vegetables
研究概览
简要总结
An observational outcome evaluation of the Lifestyle Care for Fertility program.
详细描述
This outcome evaluation will examine the feasibility and acceptability of the Whole Health Lifestyle Care for Reproductive Well-being Pilot Program ("Lifestyle Care for Fertility" or LCF) and collection of health behavior and patient-reported outcomes. Secondarily, it will also examine the longitudinal changes in health behaviors and patient-reported outcomes of participants in the Lifestyle Care for Fertility program
The Lifestyle Care for Fertility program serves women who have a fertility-related diagnosis. The program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood. Topics include meditation, sleep, yoga/exercise/movement, acupuncture, and nutrition
Participation in the program is not contingent on participation in the outcome evaluation. Patients with a uterus aged 18-50 who have a fertility-related diagnosis are eligible to participate in the program. Participants in the outcome evaluation will be a subset of the participants in the program who give their consent to researchers to collect survey and EHR data.
The outcome evaluation will collect data at 4 weeks, 8 weeks, and before, after, and in between each of the 8 weekly sessions. Data collected at baseline include demographics, PROMIS Sleep Disturbance 8a, Perceived Stress Scale 4 (PSS-4), Infertility Self Efficacy Scale (ISE), and current Health Behaviors (HB). The HB survey will be administered between Sessions 1-8, as well as after Session 8, to observe any longitudinal changes. Patients will complete the PROMIS Sleep Disturbance 8a, PSS-4, and ISE at 4 weeks and 8 weeks. Pre- and post-session data includes 0-10 NRS ratings of stress, energy, focus, well-being, perceived support (post-only), and satisfaction (post-only). Additionally, participants will complete a satisfaction survey post Session 8. All data will be collected in REDCap via a text message or email link sent to the participant. Research staff will review the participant's medical record to collect data on the participant's demographics and clinical characteristics at baseline, and to collect chemical pregnancy data at six months after the 8 sessions have been completed. Attendance data about participants will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult with a uterus aged from 18 to 50 years
- •Participating in the Lifestyle Care for Fertility program
- •Able to speak and understand English.
- •Has email address and access to mobile device with a functioning data plan.
- •Infertility-related diagnosis
排除标准
- •Age < 18 or > 50 years
- •Having a significant and uncorrected visual, hearing, or cognitive impairment
- •Inability to provide consent
- •Current pregnancy
结局指标
主要结局
Servings of Vegetables
时间窗: 8 weeks
Number of servings of vegetables consumed each day. A serving is about 1 cup of raw leafy vegetables, 1/2 cup of other cooked or raw vegetables, or 3/4 cup of raw vegetable juice.
Glasses of Water
时间窗: 8 weeks
Number of glasses (8 oz) of plain water consumed per day.
Caffeinated Beverages
时间窗: 8 weeks
Number of caffeinated beverages consumed per day.
Stretching Exercise
时间窗: 8 weeks
Frequency of stretching exercise in last week.
Sleep Hygiene
时间窗: 8 weeks
Frequency of sleep hygiene practices before bed in last week.
Self Care - Guided Imagery
时间窗: 8 weeks
Frequency of guided imagery practice in last week.
Self Care - Mindfulness/Meditation
时间窗: 8 weeks
Frequency of mindfulness/meditation practice in last week.
Self-Care - Massage Therapy
时间窗: 8 weeks
Frequency of receipt of massage therapy in last week.
Self Care - Journaling/Gratitude Journaling
时间窗: 8 weeks
Frequency of journaling or gratitude journaling in last week.
Self Care - Acupuncture/Acupressure
时间窗: 8 weeks
Frequency of receipt of acupuncture or acupressure in last week.
Self Care - Breathing Exercises
时间窗: 8 weeks
Frequency of breathing exercise practice in last week.
Aerobic Exercise
时间窗: 8 Weeks
Frequency of aerobic exercise (min 20 min) in last week.
Strengthening Exercise
时间窗: 8 weeks
Frequency of muscle strengthening exercise (min 20 min) in last week.
Hours of Sleep
时间窗: 8 weeks
Average number of hours of sleep per night in last week.
Self Care - Biofeedback
时间窗: 8 weeks
Frequency of use of biofeedback in last week.
Self Care - Progressive Relaxation
时间窗: 8 weeks
Frequency of progressive relaxation practice in last week.
Self Care - Tai Chi/Chi Gong
时间窗: 8 weeks
Frequency of Tai Chi or Chi Gong practice in last week.
Self Care - Nature Walking
时间窗: 8 weeks
Frequency of walking in nature in last week.
Servings of Fruit
时间窗: 8 weeks
Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.
次要结局
- Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA(2 hours)
- Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC(45 minutes)
- Chemical pregnancy(8 months)
- Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA(2 hours)
- Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA(2 hours)
- Recruitment Rate(4-6 weeks)
- Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC(45 minutes)
- PROMIS Sleep Disturbance 8a(8 weeks)
- Infertility Self Efficacy(8 weeks)
- Stress Change (level of stress: none [0] to worst possible [10]) - SMA(2 hours)
- Stress Change (level of stress: none [0] to worst possible [10]) - HWC(45 minutes)
- Pace of Accrual(8 weeks)
- Data Completeness(8 weeks)
- Helpfulness of group sessions in addressing needs(8 weeks)
- Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC(45 minutes)
- Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC(45 minutes)
- Retention Rate(8 weeks)
- Helpfulness of tools presented in movement session(8 weeks)
- Enjoyed health and wellness coaching session(8 weeks)
- Feedback questionnaire: Location Preference question 1(8 weeks)
- Feedback questionnaire: Length of Sessions question.(8 weeks)
- Coverage of important issues in the sessions(8 weeks)
- Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA(2 hours)
- Helpfulness of tools presented in nutrition session(8 weeks)
- Helpfulness of tools presented in relaxation and sleep session(8 weeks)
- Helpfulness of tools presented in integrate session(8 weeks)
- Enjoyed group sessions(8 weeks)
- Group setting was beneficial(8 weeks)
- Comfortable in group setting(8 weeks)
- Helpfulness of individual health coaching sessions(8 weeks)
- Feedback questionnaire: Location Preference question 2(8 weeks)
- Feedback questionnaire: Number of Sessions question.(8 weeks)
- Rating of level of support during each SMA(2 hours)
- Perceived Stress Scale - 4(8 weeks)
- Rating of level of support during HWC(45 minutes)
- Overall level of satisfaction during each SMA(2 hours)
- Overall level of satisfaction during each HWC(45 minutes)
研究者
Christine Kaiser, LAc, DACM
Principal Investigator
University Hospitals Cleveland Medical Center