DementiaNCT01843907
Patient Participation in Prevention of Loss of Functions
A study testing Empowerment and Conversation with nurse in people with Dementia and Malnutrition, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Malnutrition, Depression
- What is being tested?
- Empowerment and Conversation with nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years or older
- Living in their own home with no contact to the Municipality, both before and after admission
- Discharged from Department o105 or the Acute Receiving Unit <48 hours from admission.
Who cannot join
- Patients with life-threatening disease in the terminal stage
- Patients who does not speak and understand Danish
- Patients who are not able to communicate and collaborate, with regards to the measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.
Read the detailed description
At baseline:
Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).
At follow-up three months after discharge:
BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.
The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.
Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.
- Conditions
- Dementia, Malnutrition, Depression, Pain, Quality of Life
- Being tested
- Empowerment, Conversation with nurse
- Medical subject headings
- Dementia, Malnutrition, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpowermentBehavioural
To give patients the necessary resources to take care of their own health
Conversation with nurseOther
To find out, if the nurse, using her ....
| Study group | Role | What they receive |
|---|---|---|
| Empowerment | Other | Patients in the intervention group 1 receive a communication report which will also be sent to the physician and home care. In communication report includes the results and interpretation and explanation of the measurements in layman's terms. The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity. Links and addresses of relevant, local organizations, and networks are also included. The information material is also included in the report sent to the General Practitioner (GP) and home care. Receives: Behavioral: Empowerment |
| Conversation with Nurse | Other | Patients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities. The nurse is "blinded" in relation to the patient's screening results. Problems identified in connection therewith are communicated to the GP and home care. Receives: Other: Conversation with nurse |
| Controle Group | No intervention | Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have been readmitted to hospital
Number of participants who have been readmitted to hospital. Measured 6 months after admission.
Measured: 01.03.2013 - 12.31.2014
Secondary outcomes (3)
Mortality
Mortality. Number of participants, who have died. Measured 6 months after admission.
Measured: 01.04.2014 - 31.12.2014
Functional ability
Measured 3 months after discharge.
Functional ability
Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength
Measured: 31.12.2014
Primary Healthcare Services
Delivered services in Primary Healthcare. Measured 6 months after admission.
Measured: 01.04.2013 - 31.12.2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tove Lindhardt Damsgaard, Herlev Hospital
- Investigators
- Tove L. Damsgaard, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843907
- Sponsor's protocol ID
- H-1-2012-118
- Status last verified
- Jul 2015
- First submitted
- 20 Mar 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
- ClinicalTrials.gov ID
- NCT01843907
- Acronym / sponsor ID
- H-1-2012-118
- Conditions
- Dementia, Malnutrition, Depression, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 May 2013 (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.
Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.
Detailed description
At baseline:
Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).
At follow-up three months after discharge:
BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.
The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.
Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empowerment | Other | Behavioral: EmpowermentPatients in the intervention group 1 receive a communication report which will also be sent to the physician and home care. In communication report includes the results and interpretation and explanation of the measurements in layman's terms. The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity. Links and addresses of relevant, local organizations, and networks are also included. The information material is also included in the report sent to the General Practitioner (GP) and home care. |
| Conversation with Nurse | Other | Other: Conversation with nursePatients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities. The nurse is "blinded" in relation to the patient's screening results. Problems identified in connection therewith are communicated to the GP and home care. |
| Controle Group | No intervention | –Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years or older
- Living in their own home with no contact to the Municipality, both before and after admission
- Discharged from Department o105 or the Acute Receiving Unit <48 hours from admission.
Key exclusion criteria (3 listed)
- Patients with life-threatening disease in the terminal stage
- Patients who does not speak and understand Danish
- Patients who are not able to communicate and collaborate, with regards to the measurements
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 |
|---|---|---|
| EmpowermentTo give patients the necessary resources to take care of their own health | Behavioural | Empowerment |
| Conversation with nurseTo find out, if the nurse, using her .... | Other | Conversation with Nurse |
Primary outcome
Number of participants who have been readmitted to hospital
Time frame: 01.03.2013 - 12.31.2014
Number of participants who have been readmitted to hospital. Measured 6 months after admission.
3 secondary outcomes
Mortality
Time frame: 01.04.2014 - 31.12.2014
Functional ability
Time frame: 31.12.2014
Primary Healthcare Services
Time frame: 01.04.2013 - 31.12.2014
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 31 Jul 2015.
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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.
Tove L. Damsgaard principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment and Conversation with nurse in people with Dementia and Malnutrition, run by Herlev Hospital at 1 site in Denmark.
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 3 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 31 Jul 2015. 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 Denmark. 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?
Number of participants who have been readmitted to hospital (time frame: 01.03.2013 - 12.31.2014). 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 31 Jul 2015.