EDS, Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS), Hypermobility Syndrome
Conditions
Brief summary
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
Detailed description
The overall purpose of this study is to assess the feasibility of conducting a 9-week integrative medicine program that is comprised of a prescribed anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS), in order to determine the recruitment potential in this population and to measure the ability of individuals to complete the program. Participants will be prescribed a food plan, and adherence to and feasibility of the food plan will be measured through participant food tracking and a subjective assessment of the food plan in a brief satisfaction survey. This study aims to recruit 20 patients with HSD or EDS and make preliminary observations regarding the effects of integrative medical care on pain reduction and improved quality of life.
Interventions
BEHAVIORALAnti-inflammatory (Mediterranean-style) diet
Prescription of an anti-inflammatory diet, which encourages increasing whole fruits, vegetables, and grains, as well as balancing macronutrients (proteins, carbohydrates, and fat) for every meal.
BEHAVIORALBehavioral and psychosocial support
Capture a complete and detailed medical history and background. Discuss familial and social support, provide psychosocial support, assess the patient's current self-management strategies for self-care, and assess the patient's current self-management strategies for mental health. Recommendations will be made in accordance with the needs of the participant.
Sponsors
Healthy Living Community
National University of Natural Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65 * Beighton score of 4 or more to confirm joint hypermobility diagnosis * Baseline VAS Score of 1 or more * Not currently, or already a patient of Dr. Schaefer and Healthy Living Community * Ability to provide written informed consent * Willingness to participate in 9-week integrative medicine intervention (and make dietary and lifestyle changes) * Willingness to attend 1 in-person screening visit and 2 virtual office visits (or 3 virtual visits, if medical documentation of Beighton score can be provided in advance of enrollment, and all other criteria are met) * Access to an electronic device for MyFitnessPal food-tracker use (i.e mobile device, tablet, laptop)
Exclusion criteria
* Pregnant and lactating women, or planned pregnancy over the next 3 months * Consumption of more than 14 (men) or 7 (women) alcoholic drinks per week * History of disordered eating or eating disorder * Body mass index (BMI) considered underweight (\<18.5) * Weight loss from metastatic cancer * Unable to make dietary changes or participate in a 9-integrative medicine nutritional intervention * Those with significant dietary changes, new medications, or new exercise routines within the past 90 days * Currently, or already, a patient of Dr. Schaefer and Healthy Living Community
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 9 weeks | Number of participants enrolled per month, over the 4 month open recruitment |
| Retention rate | 9 weeks | Proportion of participants completing the mid-study or end-of-study visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the dietary recommendations | 5, 9 weeks | Estimated daily dietary intake recorded in a food tracker app |
| Adherence to food tracking | 5, 9 weeks | Reporting per week of dietary intake recorded in a food tracker app |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Baseline, 5 weeks, 9 weeks | Baseline, 5-week, and 9-week PROMIS pain intensity on a scale of 0 to 10. Higher scores represent greater intensity of pain. |
| Patient Assessment of Chronic Illness Care (PACIC+) | Baseline, 5 weeks, 9 weeks | Baseline, 5-week, and 9-week assessment. The PACIC+ consists of 26 items with Likert scale responses on a 5 point scale from Almost never to Almost always, with higher scores representing greater satisfaction with care. The PACIC provides summary scores for attitudes regarding patient-centered care, living with chronic illness, and chronic illness care. All subscales are averages of selected items that range between 1 (poor quality of care received) and 5 (excellent quality of care received). |
| Visual Analog Scale for Pain (VAS) | Baseline, 5 weeks, 9 weeks | Baseline, 5-week, and 9-week pain scale scores on a 10-point scale. The numeric measurement of pain between 0 no pain and 10 representing worst pain will be used. |
Countries
United States
Outcome results
None listed