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

September 9, 2009
July 10, 2012
August 2009
April 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00974506 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study: Complementary Therapies in Geriatric Patients
Pilot Study Complementary Therapies in Geriatric Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Geriatric Patients
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00974506
CAMGER09
No
Claudia M. Witt, MD, Institute for Social Medicine, Epidemiology, and Health Economics, Charité
Charite University, Berlin, Germany
  • Homöopathie Stiftung
  • omoeon e.V.
Principal Investigator: Claudia M Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Charite University, Berlin, Germany
September 2009

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