Malnutrition Clinical Trial
Official title:
Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)
NCT number | NCT03314350 |
Other study ID # | WONDER |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | January 31, 2021 |
In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.
Status | Recruiting |
Enrollment | 517 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Age = 60 years - Informed written consent - Normal cognitive status according to Mini-Mental State Examination (MMSE = 24 points) - Life expectancy of > 3 months according to treating doctor - Proficient in German Exclusion Criteria: - Lack or incapacity of informed consent - MMSE < 24 - Life expectancy < 3 months according to assessment by the attending physician - Short term patients (< 3 days of hospital stay) - Lack of German language |
Country | Name | City | State |
---|---|---|---|
Germany | Charite University Medicine, Research Group on Geriatrics | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJ, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010 Sep;26(9):886-9. doi: 10.1016/j.nut.2010.01.016. Epub 2010 May 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of wound healing disturbances | Number of wound healing disturbances upon admission to the hospital in General | Baseline | |
Secondary | Nutritional Parameter | Mini Nutritional Assessment - Short Form (questionnaire) | Baseline and up to 3 weeks | |
Secondary | Functional Parameter | Timed Up & Go Test | Baseline and up to 3 weeks | |
Secondary | Functional Parameter | 4m-walk Test to measure gait speed | Baseline and up to 3 weeks | |
Secondary | Functional Parameter | Lung Test to measure respiratory force | Baseline and up to 3 weeks | |
Secondary | Strength Parameter | Hand grip strength | Baseline and up to 3 weeks | |
Secondary | Strength Parameter | Knee extension strength | Baseline and up to 3 weeks | |
Secondary | Frailty | Frailty Status according to Fried criteria | Baseline and up to 3 weeks | |
Secondary | Index of quality of life | EQ-5D-5L (questionnaire) to measure quality of life | Baseline and up to 3 weeks, after 3 months and after 6 months | |
Secondary | Body composition | Bioelectric impedance analysis | Baseline and up to 3 weeks |
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