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Pilot Study: Complementary Therapies in Geriatric Patients

NCT ID: NCT00974506

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-10-31

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:

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.

Detailed Description

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Conditions

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Geriatric Patients

Keywords

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geriatric patients living in residential community (shared flats), multiple disease-conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAM-intervention

Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner

Group Type ACTIVE_COMPARATOR

CAM-intervention

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Routine care therapy

Intervention Type OTHER

Routine care therapy by general practitioner

Interventions

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CAM-intervention

Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner

Intervention Type OTHER

Routine care therapy

Routine care therapy by general practitioner

Intervention Type OTHER

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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Homöopathie Stiftung

UNKNOWN

Sponsor Role collaborator

omoeon e.V.

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Institute for Social Medicine, Epidemiology, and Health Economics, Charité

Principal Investigators

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Claudia M Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany

Locations

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Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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CAMGER09

Identifier Type: -

Identifier Source: org_study_id