Pilot Study: Complementary Therapies in Geriatric Patients

Geriatric Patients Clinical Trial

Official title:

Pilot Study Complementary Therapies in Geriatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974506
• Other study ID #: CAMGER09
• 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

• Geriatric Patients

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