Pilot Study: Complementary Therapies in Geriatric Patients

July 10, 2012 updated by: Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of motor and process skills (AMPS)
Time Frame: 3, 6, 12 months
3, 6, 12 months
Qualidem
Time Frame: 3, 6, 12 months
3, 6, 12 months
Barthel Index
Time Frame: 3, 6, 12 months
3, 6, 12 months
Nurses Observation Scale for Geriatric Patients
Time Frame: 3, 6, 12 months
3, 6, 12 months
Minimental Status Test
Time Frame: 12 months
12 months
Tinetti Test
Time Frame: 3, 6, 12 months
3, 6, 12 months
Profile of Wellbeing
Time Frame: 3, 6, 12 months
3, 6, 12 months
Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003)
Time Frame: 3, 6, 12 months
3, 6, 12 months
Falls (Esslinger Sturzprotokoll)
Time Frame: 12 months
12 months
hospital admissions
Time Frame: 12 months
12 months
Adverse effects
Time Frame: 12 months
12 months
Interviews with health care team and relatives.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAMGER09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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