Fertility Issues
Conditions
Keywords
fertility, shared medical appointments, health coaching, quality of life
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.
Interventions
BEHAVIORALWhole 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.
Sponsors
Christine Kaiser, LAc, DACM
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Servings of Fruit | 8 weeks | Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit. |
| Servings of Vegetables | 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 | 8 weeks | Number of glasses (8 oz) of plain water consumed per day. |
| Caffeinated Beverages | 8 weeks | Number of caffeinated beverages consumed per day. |
| Aerobic Exercise | 8 Weeks | Frequency of aerobic exercise (min 20 min) in last week. |
| Strengthening Exercise | 8 weeks | Frequency of muscle strengthening exercise (min 20 min) in last week. |
| Stretching Exercise | 8 weeks | Frequency of stretching exercise in last week. |
| Sleep Hygiene | 8 weeks | Frequency of sleep hygiene practices before bed in last week. |
| Hours of Sleep | 8 weeks | Average number of hours of sleep per night in last week. |
| Self Care - Biofeedback | 8 weeks | Frequency of use of biofeedback in last week. |
| Self Care - Breathing Exercises | 8 weeks | Frequency of breathing exercise practice in last week. |
| Self Care - Guided Imagery | 8 weeks | Frequency of guided imagery practice in last week. |
| Self Care - Mindfulness/Meditation | 8 weeks | Frequency of mindfulness/meditation practice in last week. |
| Self Care - Progressive Relaxation | 8 weeks | Frequency of progressive relaxation practice in last week. |
| Self Care - Journaling/Gratitude Journaling | 8 weeks | Frequency of journaling or gratitude journaling in last week. |
| Self Care - Tai Chi/Chi Gong | 8 weeks | Frequency of Tai Chi or Chi Gong practice in last week. |
| Self-Care - Massage Therapy | 8 weeks | Frequency of receipt of massage therapy in last week. |
| Self Care - Acupuncture/Acupressure | 8 weeks | Frequency of receipt of acupuncture or acupressure in last week. |
| Self Care - Nature Walking | 8 weeks | Frequency of walking in nature in last week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data Completeness | 8 weeks | Percent of data collection that is completed |
| Helpfulness of group sessions in addressing needs | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Coverage of important issues in the sessions | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Helpfulness of tools presented in nutrition session | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Helpfulness of tools presented in movement session | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Enjoyed group sessions | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Enjoyed health and wellness coaching session | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Group setting was beneficial | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Comfortable in group setting | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Helpfulness of individual health coaching sessions | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Feedback questionnaire: Location Preference question 1 | 8 weeks | Shared Medical Appointment session location preference. Choices: virtual, in person or no preference. |
| Feedback questionnaire: Location Preference question 2 | 8 weeks | Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference. |
| Feedback questionnaire: Number of Sessions question. | 8 weeks | Opinion on number of sessions. Choices: too few, just right, too many. |
| Feedback questionnaire: Length of Sessions question. | 8 weeks | Opinion on length of sessions. Choices: too short, just right, too long. |
| Rating of level of support during each SMA | 2 hours | 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. |
| Rating of level of support during HWC | 45 minutes | 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. |
| Helpfulness of tools presented in relaxation and sleep session | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| Overall level of satisfaction during each HWC | 45 minutes | 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. |
| Overall level of satisfaction during each SMA | 2 hours | 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. |
| Helpfulness of tools presented in integrate session | 8 weeks | 5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes) |
| PROMIS Sleep Disturbance 8a | 8 weeks | 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. |
| Perceived Stress Scale - 4 | 8 weeks | Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress. |
| Infertility Self Efficacy | 8 weeks | 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. |
| Chemical pregnancy | 8 months | Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion. |
| Stress Change (level of stress: none [0] to worst possible [10]) - SMA | 2 hours | 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. |
| Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA | 2 hours | 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. |
| Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA | 2 hours | 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. |
| Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA | 2 hours | 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. |
| Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA | 2 hours | 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. |
| Stress Change (level of stress: none [0] to worst possible [10]) - HWC | 45 minutes | 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. |
| Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC | 45 minutes | 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. |
| Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC | 45 minutes | 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. |
| Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC | 45 minutes | 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. |
| Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC | 45 minutes | 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. |
| Recruitment Rate | 4-6 weeks | Number enrolled over number approached. |
| Retention Rate | 8 weeks | Percent of participants retained at each data collection point |
| Pace of Accrual | 8 weeks | Number of participants enrolled from each program cohort. |
Countries
United States
Outcome results
None listed