Pilot Study: Complementary Therapies in Geriatric Patients

Study Overview
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Brief Summary
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In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared: a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner routine care by general practitioner The investigators assess the effect of the complex intervention on activities of daily living (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication use. The results of this exploratory study are needed to plan a randomized controlled trial (RCT) with confirmatory design in the future.

Official Title
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Pilot Study Complementary Therapies in Geriatric Patients

Conditions
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Geriatric Patients

Intervention / Treatment
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* Other: CAM-intervention
* Other: Routine care therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: living in shared flat/residential community informed consent of patient or authorized representative Exclusion Criteria: participation in another study within the last 6 months acute or chronic disease condition that does not allow participation actual use of complementary therapies

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAM-intervention<br>Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner | Other: CAM-intervention<br>* Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner<br>|
| Active Comparator: Routine care therapy<br>Routine care therapy by general practitioner | Other: Routine care therapy<br>* Routine care therapy by general practitioner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of motor and process skills (AMPS) |  | 3, 6, 12 months | 
| Qualidem |  | 3, 6, 12 months | 
| Barthel Index |  | 3, 6, 12 months | 
| Nurses Observation Scale for Geriatric Patients |  | 3, 6, 12 months | 
| Minimental Status Test |  | 12 months | 
| Tinetti Test |  | 3, 6, 12 months | 
| Profile of Wellbeing |  | 3, 6, 12 months | 
| Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003) |  | 3, 6, 12 months | 
| Falls (Esslinger Sturzprotokoll) |  | 12 months | 
| hospital admissions |  | 12 months | 
| Adverse effects |  | 12 months | 
| Interviews with health care team and relatives. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric patients living in residential community (shared flats), multiple disease-conditions