Lifestyle Care for Fertility Outcome Evaluation

Fertility Issues Clinical Trial

— PROWESS  

Official title:

Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297070
• Other study ID #: STUDY20231406
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Christine Kaiser, DACM LAc
• Phone: (216) 285-4070
• Email: Christine.Kaiser[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

Intervention

Behavioral:
• Whole Health Lifestyle Care for Reproductive Well-being pilot program
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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Christine Kaiser, LAc, DACM

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Servings of Fruit	Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.	8 weeks
Primary	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.	8 weeks
Primary	Glasses of Water	Number of glasses (8 oz) of plain water consumed per day.	8 weeks
Primary	Caffeinated Beverages	Number of caffeinated beverages consumed per day.	8 weeks
Primary	Aerobic Exercise	Frequency of aerobic exercise (min 20 min) in last week.	8 Weeks
Primary	Strengthening Exercise	Frequency of muscle strengthening exercise (min 20 min) in last week.	8 weeks
Primary	Stretching Exercise	Frequency of stretching exercise in last week.	8 weeks
Primary	Sleep Hygiene	Frequency of sleep hygiene practices before bed in last week.	8 weeks
Primary	Hours of Sleep	Average number of hours of sleep per night in last week.	8 weeks
Primary	Self Care - Biofeedback	Frequency of use of biofeedback in last week.	8 weeks
Primary	Self Care - Breathing Exercises	Frequency of breathing exercise practice in last week.	8 weeks
Primary	Self Care - Guided Imagery	Frequency of guided imagery practice in last week.	8 weeks
Primary	Self Care - Mindfulness/Meditation	Frequency of mindfulness/meditation practice in last week.	8 weeks
Primary	Self Care - Progressive Relaxation	Frequency of progressive relaxation practice in last week.	8 weeks
Primary	Self Care - Journaling/Gratitude Journaling	Frequency of journaling or gratitude journaling in last week.	8 weeks
Primary	Self Care - Tai Chi/Chi Gong	Frequency of Tai Chi or Chi Gong practice in last week.	8 weeks
Primary	Self-Care - Massage Therapy	Frequency of receipt of massage therapy in last week.	8 weeks
Primary	Self Care - Acupuncture/Acupressure	Frequency of receipt of acupuncture or acupressure in last week.	8 weeks
Primary	Self Care - Nature Walking	Frequency of walking in nature in last week.	8 weeks
Secondary	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.	8 weeks
Secondary	Perceived Stress Scale - 4	Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress.	8 weeks
Secondary	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.	8 weeks
Secondary	Chemical pregnancy	Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion.	8 months
Secondary	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.	2 hours
Secondary	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.	2 hours
Secondary	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.	2 hours
Secondary	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.	2 hours
Secondary	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.	2 hours
Secondary	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.	45 minutes
Secondary	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.	45 minutes
Secondary	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.	45 minutes
Secondary	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.	45 minutes
Secondary	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.	45 minutes
Secondary	Recruitment Rate	Number enrolled over number approached.	4-6 weeks
Secondary	Retention Rate	Percent of participants retained at each data collection point	8 weeks
Secondary	Pace of Accrual	Number of participants enrolled from each program cohort.	8 weeks
Secondary	Data Completeness	Percent of data collection that is completed	8 weeks
Secondary	Helpfulness of group sessions in addressing needs	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Coverage of important issues in the sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Helpfulness of tools presented in nutrition session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Helpfulness of tools presented in movement session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	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)	8 weeks
Secondary	Helpfulness of tools presented in integrate session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Enjoyed group sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Enjoyed health and wellness coaching session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Group setting was beneficial	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Comfortable in group setting	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Helpfulness of individual health coaching sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Secondary	Feedback questionnaire: Location Preference question 1	Shared Medical Appointment session location preference. Choices: virtual, in person or no preference.	8 weeks
Secondary	Feedback questionnaire: Location Preference question 2	Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference.	8 weeks
Secondary	Feedback questionnaire: Number of Sessions question.	Opinion on number of sessions. Choices: too few, just right, too many.	8 weeks
Secondary	Feedback questionnaire: Length of Sessions question.	Opinion on length of sessions. Choices: too short, just right, too long.	8 weeks
Secondary	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.	2 hours
Secondary	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.	45 minutes
Secondary	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.	2 hours
Secondary	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.	45 minutes