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| Name | Class |
|---|---|
| Healthy Living Community | UNKNOWN |
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A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Medicine | Other | Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory (Mediterranean-style) diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of participants enrolled per month, over the 4 month open recruitment | 9 weeks |
| Retention rate | Proportion of participants completing the mid-study or end-of-study visits | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the dietary recommendations | Estimated daily dietary intake recorded in a food tracker app | 5, 9 weeks |
| Adherence to food tracking | Reporting per week of dietary intake recorded in a food tracker app |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Pain (VAS) | 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. | Baseline, 5 weeks, 9 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rich Barrett, ND | NUNM Institutional Review Board Chair | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Natural Medicine | Portland | Oregon | 97201 | United States | ||
| Healthy Living Community |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38353245 | Derived | Guedry SE, Langley BO, Schaefer K, Hanes DA. Integrative medicine for hypermobility spectrum disorders (HSD) and Ehlers-Danlos syndromes (EDS): a feasibility study. Disabil Rehabil. 2024 Dec;46(24):5854-5867. doi: 10.1080/09638288.2024.2314713. Epub 2024 Feb 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 9, 2023 | |
| Reset | Jan 19, 2024 | |
| Release | Mar 30, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2021 |
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Feasibility study
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| Behavioral and psychosocial support | Behavioral | 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. |
|
| 5, 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. |
| Baseline, 5 weeks, 9 weeks |
| Patient Assessment of Chronic Illness Care (PACIC+) | 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). | Baseline, 5 weeks, 9 weeks |
| Portland |
| Oregon |
| 97202 |
| United States |
| Reset | Apr 17, 2026 |
| Mar 5, 2021 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2020 | Jan 20, 2021 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 9, 2023 | Jan 19, 2024 | |||
| Mar 30, 2026 | Apr 17, 2026 |
| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| C536196 | Ehlers-Danlos syndrome type 3 |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| D004032 | Diet |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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