NCT00974506

Brief Summary

In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:

  1. 1.a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner
  2. 2.routine care by general practitioner

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 11, 2012

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

September 9, 2009

Last Update Submit

July 10, 2012

Conditions

Keywords

geriatric patients living in residential community (shared flats), multiple disease-conditions

Outcome Measures

Secondary Outcomes (12)

  • Assessment of motor and process skills (AMPS)

    3, 6, 12 months

  • Qualidem

    3, 6, 12 months

  • Barthel Index

    3, 6, 12 months

  • Nurses Observation Scale for Geriatric Patients

    3, 6, 12 months

  • Minimental Status Test

    12 months

  • +7 more secondary outcomes

Study Arms (2)

CAM-intervention

ACTIVE COMPARATOR

Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner

Other: CAM-intervention

Routine care therapy

ACTIVE COMPARATOR

Routine care therapy by general practitioner

Other: Routine care therapy

Interventions

Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner

CAM-intervention

Routine care therapy by general practitioner

Routine care therapy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • living in shared flat/residential community
  • informed consent of patient or authorized representative

You may not qualify if:

  • participation in another study within the last 6 months
  • acute or chronic disease condition that does not allow participation
  • actual use of complementary therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Study Officials

  • Claudia M Witt, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

July 11, 2012

Record last verified: 2009-09

Locations