Pilot Study: Complementary Therapies in Geriatric Patients

This study has been completed.

Sponsor:

Collaborators:

Homöopathie Stiftung

omoeon e.V.

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00974506

First received: September 9, 2009

Last updated: July 10, 2012

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2009

Last Updated Date

July 10, 2012

Start Date ^ICMJE

August 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00974506 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pilot Study: Complementary Therapies in Geriatric Patients

Official Title ^ICMJE

Pilot Study Complementary Therapies in Geriatric Patients

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Geriatric Patients

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Other: CAM-intervention
Active Comparator: Routine care therapy
Routine care therapy by general practitioner

Intervention: Other: Routine care therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00974506

Other Study ID Numbers ^ICMJE

CAMGER09

Has Data Monitoring Committee

Responsible Party

Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Homöopathie Stiftung
omoeon e.V.

Investigators ^ICMJE

Principal Investigator:

Claudia M Witt, MD

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

Information Provided By

Charite University, Berlin, Germany

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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