Quality of Life for Geriatric Patients.ESAQoGeNCT01681056
Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients
A study testing Autosuggestion for 30 days in people with Quality of Life for Geriatric Patients., run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Quality of Life for Geriatric Patients.
- What is being tested?
- Autosuggestion for 30 days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2010to Feb 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 60 years old with multipathology, inpatients
- Not in steroid therapy
- Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)
- Cooperative
- Willing to go through all of the research steps.
Who cannot join
- Stroke
- Multiple Sclerosis
- Brain Tumour
- Using Pace maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion
The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life.
The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.
Read the detailed description
Geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. Autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and control groups received usual standard medical therapy.
Baseline data were collected within one week after admission. Then the subject will be followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2, interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system by Magnetic Resonance Spectroscopy.
- Conditions
- Quality of Life for Geriatric Patients.
- Being tested
- Autosuggestion for 30 days
- Keywords
- autosuggestion, quality of life, geriatric, serum cortisol, Interferon gamma, interleukin-2, interleukin-6, neuroplasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autosuggestion for 30 daysBehavioural
Also called Self talk
| Study group | Role | What they receive |
|---|---|---|
| Autosuggestion | Experimental | Not described Receives: Behavioral: Autosuggestion for 30 days |
| Standard medical theraphy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured by COOP chart
Measured: 30 days
Secondary outcomes (5)
Serum Cortisol (ng/mL)
Change from baseline in Serum Cortisol concentration (ng/mL) measured by Radioimmunoassay method at 08.00-09.00 am.
Measured: 30 days
Interleukin-2 (pg/mL)
Change from baseline in Interleukin-2 concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.
Measured: 30 days
Interleukin-6 (pg/mL)
Change from baseline in Interleukin-6 concentration(pg/mL) measured by ELISA method at 08.00-09.00 am.
Measured: 30 days
Interferon Gamma (pg/mL)
Change from baseline in Interferon Gamma concentration (pg/mL) measured by ELISA method at 08.00-09.00 am.
Measured: 30 days
N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)
Ratio change from baseline by Magnetic Resonance Spectroscopy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life for Geriatric Patients.Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Kemala Sari, MD, Universitas Indonesia
- Investigators
- Nina K Sari, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681056
- Sponsor's protocol ID
- U1111-1134-1994
- Acronym
- ESAQoGe
- Status last verified
- Oct 2012
- First submitted
- 4 Sep 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Psycho-Neuro-Endocrine-Immunology Pathway of Geriatric Patients: A Trial of Autosuggestion
- ClinicalTrials.gov ID
- NCT01681056
- Acronym / sponsor ID
- ESAQoGe / U1111-1134-1994
- Conditions
- Quality of Life for Geriatric Patients.
- Keywords
- autosuggestion, quality of life, geriatric, serum cortisol, Interferon gamma, interleukin-2, interleukin-6, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Sep 2012 (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.
The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life.
The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.
Detailed description
Geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. Autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and control groups received usual standard medical therapy.
Baseline data were collected within one week after admission. Then the subject will be followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2, interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system by Magnetic Resonance Spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autosuggestion | Experimental | Behavioral: Autosuggestion for 30 days |
| Standard medical theraphy | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥ 60 years old with multipathology, inpatients
- Not in steroid therapy
- Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)
- Cooperative
- Willing to go through all of the research steps.
Key exclusion criteria (4 listed)
- Stroke
- Multiple Sclerosis
- Brain Tumour
- Using Pace maker
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 |
|---|---|---|
| Autosuggestion for 30 daysAlso: Self talk | Behavioural | Autosuggestion |
Primary outcome
Quality of Life
Time frame: 30 days
Measured by COOP chart
5 secondary outcomes
Serum Cortisol (ng/mL)
Time frame: 30 days
Interleukin-2 (pg/mL)
Time frame: 30 days
Interleukin-6 (pg/mL)
Time frame: 30 days
Interferon Gamma (pg/mL)
Time frame: 30 days
N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system (amygdala, hippocampus, hypothalamus, temporal lobe, accumbens nuclei, prefrontal cortex)
Time frame: 30 days
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 3 Oct 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.
Nina K Sari, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autosuggestion for 30 days in people with Quality of Life for Geriatric Patients., run by Universitas Indonesia at 1 site in Indonesia.
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 5 inclusion and 4 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 3 Oct 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 Indonesia. 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.
What does the primary outcome measure?
Quality of Life (time frame: 30 days). It is what the study was designed to measure, not a finding.
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 3 Oct 2012.