Clinical trial NCT06297070: Lifestyle Care for Fertility Outcome Evaluation
Official title: Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Issues
Keywords: fertility
shared medical appointments
health coaching
quality of life
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program

Brief summary: An observational outcome evaluation of the Lifestyle Care for Fertility program.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \< 18 or \> 50 years
* Having a significant and uncorrected visual, hearing, or cognitive impairment
* Inability to provide consent
* Current pregnancy

Primary outcomes:
measure: Servings of Fruit
timeFrame: 8 weeks
measure: Servings of Vegetables
timeFrame: 8 weeks
measure: Glasses of Water
timeFrame: 8 weeks
measure: Caffeinated Beverages
timeFrame: 8 weeks
measure: Aerobic Exercise
timeFrame: 8 Weeks
measure: Strengthening Exercise
timeFrame: 8 weeks
measure: Stretching Exercise
timeFrame: 8 weeks
measure: Sleep Hygiene
timeFrame: 8 weeks
measure: Hours of Sleep
timeFrame: 8 weeks
measure: Self Care - Biofeedback
timeFrame: 8 weeks
measure: Self Care - Breathing Exercises
timeFrame: 8 weeks
measure: Self Care - Guided Imagery
timeFrame: 8 weeks
measure: Self Care - Mindfulness/Meditation
timeFrame: 8 weeks
measure: Self Care - Progressive Relaxation
timeFrame: 8 weeks
measure: Self Care - Journaling/Gratitude Journaling
timeFrame: 8 weeks
measure: Self Care - Tai Chi/Chi Gong
timeFrame: 8 weeks
measure: Self-Care - Massage Therapy
timeFrame: 8 weeks
measure: Self Care - Acupuncture/Acupressure
timeFrame: 8 weeks
measure: Self Care - Nature Walking
timeFrame: 8 weeks
Secondary outcomes:
measure: PROMIS Sleep Disturbance 8a
timeFrame: 8 weeks
measure: Perceived Stress Scale - 4
timeFrame: 8 weeks
measure: Infertility Self Efficacy
timeFrame: 8 weeks
measure: Chemical pregnancy
timeFrame: 8 months
measure: Stress Change (level of stress: none [0] to worst possible [10]) - SMA
timeFrame: 2 hours
measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA
timeFrame: 2 hours
measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA
timeFrame: 2 hours
measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA
timeFrame: 2 hours
measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA
timeFrame: 2 hours
measure: Stress Change (level of stress: none [0] to worst possible [10]) - HWC
timeFrame: 45 minutes
measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC
timeFrame: 45 minutes
measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC
timeFrame: 45 minutes
measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC
timeFrame: 45 minutes
measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC
timeFrame: 45 minutes
measure: Recruitment Rate
timeFrame: 4-6 weeks
measure: Retention Rate
timeFrame: 8 weeks
measure: Pace of Accrual
timeFrame: 8 weeks
measure: Data Completeness
timeFrame: 8 weeks
measure: Helpfulness of group sessions in addressing needs
timeFrame: 8 weeks
measure: Coverage of important issues in the sessions
timeFrame: 8 weeks
measure: Helpfulness of tools presented in nutrition session
timeFrame: 8 weeks
measure: Helpfulness of tools presented in movement session
timeFrame: 8 weeks
measure: Helpfulness of tools presented in relaxation and sleep session
timeFrame: 8 weeks
measure: Helpfulness of tools presented in integrate session
timeFrame: 8 weeks
measure: Enjoyed group sessions
timeFrame: 8 weeks
measure: Enjoyed health and wellness coaching session
timeFrame: 8 weeks
measure: Group setting was beneficial
timeFrame: 8 weeks
measure: Comfortable in group setting
timeFrame: 8 weeks
measure: Helpfulness of individual health coaching sessions
timeFrame: 8 weeks
measure: Feedback questionnaire: Location Preference question 1
timeFrame: 8 weeks
measure: Feedback questionnaire: Location Preference question 2
timeFrame: 8 weeks
measure: Feedback questionnaire: Number of Sessions question.
timeFrame: 8 weeks
measure: Feedback questionnaire: Length of Sessions question.
timeFrame: 8 weeks
measure: Rating of level of support during each SMA
timeFrame: 2 hours
measure: Rating of level of support during HWC
timeFrame: 45 minutes
measure: Overall level of satisfaction during each SMA
timeFrame: 2 hours
measure: Overall level of satisfaction during each HWC
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Christine Kaiser, DACM LAc
role: PRINCIPAL_INVESTIGATOR
References: