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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
  Purpose

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.


Condition Intervention
Geriatric Patients
 Other: CAM-intervention
Other: Routine care therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Complementary Therapies in Geriatric Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CAM-intervention
Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner
 Other: CAM-intervention
Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner
Active Comparator: Routine care therapy
Routine care therapy by general practitioner
 Other: Routine care therapy
Routine care therapy by general practitioner

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974506

Locations
Germany
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Homöopathie Stiftung
omoeon e.V.
Investigators
Principal Investigator: Claudia M Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité
ClinicalTrials.gov Identifier: NCT00974506     History of Changes
Other Study ID Numbers: CAMGER09
Study First Received: September 9, 2009
Last Updated: July 10, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
geriatric patients living in residential community (shared flats), multiple disease-conditions

ClinicalTrials.gov processed this record on May 23, 2013