Geriatric PatientsNCT00974506
Pilot Study: Complementary Therapies in Geriatric Patients
A study testing CAM-intervention and Routine care therapy in people with Geriatric Patients, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- CAM-intervention and Routine care therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- living in shared flat/residential community
- informed consent of patient or authorized representative
Who cannot join
- participation in another study within the last 6 months
- acute or chronic disease condition that does not allow participation
- actual use of complementary therapies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, State of Berlin, 10117
About this study
Official title: 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:
- a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner
- routine care by general practitioner
Read more
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.
- Conditions
- Geriatric Patients
- Being tested
- CAM-intervention, Routine care therapy
- Keywords
- geriatric patients living in residential community (shared flats), multiple disease-conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM-interventionOther
Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner
Routine care therapyOther
Routine care therapy by general practitioner
| Study group | Role | What they receive |
|---|---|---|
| CAM-intervention | Active comparator | Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner Receives: Other: CAM-intervention |
| Routine care therapy | Active comparator | Routine care therapy by general practitioner Receives: Other: Routine care therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric PatientsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Homöopathie Stiftung, omoeon e.V.
- Investigators
- Claudia M Witt, MD, Principal investigator, Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974506
- Sponsor's protocol ID
- CAMGER09
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2009
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Complementary Therapies in Geriatric Patients
- ClinicalTrials.gov ID
- NCT00974506
- Acronym / sponsor ID
- CAMGER09
- Conditions
- Geriatric Patients
- Keywords
- geriatric patients living in residential community (shared flats), multiple disease-conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Homöopathie Stiftung, omoeon e.V.
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:
- a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM-intervention | Active comparator | Other: CAM-interventionComplex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine therapy by general practitioner |
| Routine care therapy | Active comparator | Other: Routine care therapyRoutine care therapy by general practitioner |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- living in shared flat/residential community
- informed consent of patient or authorized representative
Key exclusion criteria (3 listed)
- participation in another study within the last 6 months
- acute or chronic disease condition that does not allow participation
- actual use of complementary therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAM-interventionComplex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner | Other | CAM-intervention |
| Routine care therapyRoutine care therapy by general practitioner | Other | Routine care therapy |
Primary outcome
Not reported in the source record.
12 secondary outcomes
Assessment of motor and process skills (AMPS)
Time frame: 3, 6, 12 months
Qualidem
Time frame: 3, 6, 12 months
Barthel Index
Time frame: 3, 6, 12 months
Nurses Observation Scale for Geriatric Patients
Time frame: 3, 6, 12 months
Minimental Status Test
Time frame: 12 months
Tinetti Test
Time frame: 3, 6, 12 months
Profile of Wellbeing
Time frame: 3, 6, 12 months
Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003)
Time frame: 3, 6, 12 months
Falls (Esslinger Sturzprotokoll)
Time frame: 12 months
hospital admissions
Time frame: 12 months
Adverse effects
Time frame: 12 months
Interviews with health care team and relatives.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Witt, MD principal investigator
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAM-intervention and Routine care therapy in people with Geriatric Patients, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.