An observational outcome evaluation of the Lifestyle Care for Fertility program.
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.
Study Type
OBSERVATIONAL
Enrollment
44
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.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Servings of Fruit
Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.
Time frame: 8 weeks
Servings of Vegetables
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.
Time frame: 8 weeks
Glasses of Water
Number of glasses (8 oz) of plain water consumed per day.
Time frame: 8 weeks
Caffeinated Beverages
Number of caffeinated beverages consumed per day.
Time frame: 8 weeks
Aerobic Exercise
Frequency of aerobic exercise (min 20 min) in last week.
Time frame: 8 Weeks
Strengthening Exercise
Frequency of muscle strengthening exercise (min 20 min) in last week.
Time frame: 8 weeks
Stretching Exercise
Frequency of stretching exercise in last week.
Time frame: 8 weeks
Sleep Hygiene
Frequency of sleep hygiene practices before bed in last week.
Time frame: 8 weeks
Hours of Sleep
Average number of hours of sleep per night in last week.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Self Care - Biofeedback
Frequency of use of biofeedback in last week.
Time frame: 8 weeks
Self Care - Breathing Exercises
Frequency of breathing exercise practice in last week.
Time frame: 8 weeks
Self Care - Guided Imagery
Frequency of guided imagery practice in last week.
Time frame: 8 weeks
Self Care - Mindfulness/Meditation
Frequency of mindfulness/meditation practice in last week.
Time frame: 8 weeks
Self Care - Progressive Relaxation
Frequency of progressive relaxation practice in last week.
Time frame: 8 weeks
Self Care - Journaling/Gratitude Journaling
Frequency of journaling or gratitude journaling in last week.
Time frame: 8 weeks
Self Care - Tai Chi/Chi Gong
Frequency of Tai Chi or Chi Gong practice in last week.
Time frame: 8 weeks
Self-Care - Massage Therapy
Frequency of receipt of massage therapy in last week.
Time frame: 8 weeks
Self Care - Acupuncture/Acupressure
Frequency of receipt of acupuncture or acupressure in last week.
Time frame: 8 weeks
Self Care - Nature Walking
Frequency of walking in nature in last week.
Time frame: 8 weeks
PROMIS Sleep Disturbance 8a
Composite score (8 -40 with higher scores representing a better outcome) measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days.
Time frame: 8 weeks
Perceived Stress Scale - 4
Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress.
Time frame: 8 weeks
Infertility Self Efficacy
Composite score (16-144 with higher scores representing a better outcome) measuring self-reported perceived self-efficacy for coping with a diagnosis and treatment for infertility.
Time frame: 8 weeks
Chemical pregnancy
Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion.
Time frame: 8 months
Stress Change (level of stress: none [0] to worst possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in stress level from pre to post each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Stress Change (level of stress: none [0] to worst possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in stress level from pre to post each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC
Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Recruitment Rate
Number enrolled over number approached.
Time frame: 4-6 weeks
Retention Rate
Percent of participants retained at each data collection point
Time frame: 8 weeks
Pace of Accrual
Number of participants enrolled from each program cohort.
Time frame: 8 weeks
Data Completeness
Percent of data collection that is completed
Time frame: 8 weeks
Helpfulness of group sessions in addressing needs
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Coverage of important issues in the sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Helpfulness of tools presented in nutrition session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Helpfulness of tools presented in movement session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Helpfulness of tools presented in relaxation and sleep session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Helpfulness of tools presented in integrate session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Enjoyed group sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Enjoyed health and wellness coaching session
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Group setting was beneficial
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Comfortable in group setting
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Helpfulness of individual health coaching sessions
5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)
Time frame: 8 weeks
Feedback questionnaire: Location Preference question 1
Shared Medical Appointment session location preference. Choices: virtual, in person or no preference.
Time frame: 8 weeks
Feedback questionnaire: Location Preference question 2
Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference.
Time frame: 8 weeks
Feedback questionnaire: Number of Sessions question.
Opinion on number of sessions. Choices: too few, just right, too many.
Time frame: 8 weeks
Feedback questionnaire: Length of Sessions question.
Opinion on length of sessions. Choices: too short, just right, too long.
Time frame: 8 weeks
Rating of level of support during each SMA
11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Rating of level of support during HWC
11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes
Overall level of satisfaction during each SMA
11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 shared medical appointment sessions.
Time frame: 2 hours
Overall level of satisfaction during each HWC
11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 health and wellness coaching sessions.
Time frame: 45 minutes