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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00974506
Other study ID # CAMGER09
Secondary ID
Status Completed
Phase N/A
First received September 9, 2009
Last updated July 10, 2012
Start date August 2009
Est. completion date October 2011

Study information

Verified date September 2009
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:

1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
CAM-intervention
Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner
Routine care therapy
Routine care therapy by general practitioner

Locations

Country Name City State
Germany Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center Berlin

Sponsors (3)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Homöopathie Stiftung, omoeon e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Secondary Assessment of motor and process skills (AMPS) 3, 6, 12 months No
Secondary Qualidem 3, 6, 12 months No
Secondary Barthel Index 3, 6, 12 months No
Secondary Nurses Observation Scale for Geriatric Patients 3, 6, 12 months No
Secondary Minimental Status Test 12 months No
Secondary Tinetti Test 3, 6, 12 months Yes
Secondary Profile of Wellbeing 3, 6, 12 months No
Secondary Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003) 3, 6, 12 months No
Secondary Falls (Esslinger Sturzprotokoll) 12 months Yes
Secondary hospital admissions 12 months No
Secondary Adverse effects 12 months Yes
Secondary Interviews with health care team and relatives. 12 months No
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