Multiple ConditionsNCT01597882
Improving Monitoring of Patients Receiving Case Management
An observational study of Multiple Conditions and Coronary Heart Disease, run by University of Southampton at 2 sites in United Kingdom.
Trial summary
The UK population is ageing and the likelihood of having a long term health condition increases with age. Three out of every five people over 60 in the UK have a long term condition. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Conditions, Coronary Heart Disease, Diabetes
- How many people
- 114 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2012to Dec 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Older adult
Study population: Patients receiving cmmunity health case management.
Who may be able to join
- Patients aged 65 years or over receiving health case management in the community.
Who cannot join
- Enrolled in any other research study
- Preclude consent:
- Significant cognitive impairment resulting in lack of capacity to consent. b. Unable to communicate without significant aids e.g. Non-English speaking.
- Preclude participation/ collection of data
- Significant emotional distress or psychotic illness active within the last 6 months.
- Receiving end of life care.
Show all 9Show fewer
- Current illness that would preclude data collection.
- Upper limb pathology that would limit participation e.g. bone fracture within the previous 6 months.
- Identified as high risk patients with regards to lone working safety by their case manager.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Solent NHS Trust
Portsmouth, PO4 8LD
Southern Health NHS Foundation Trust
Southampton, PO13 0FH
About this study
Official title: Improved Targeting of Admission Avoidance Interventions in Older People With Long-term Conditions:An Observational,Longitudinal Study Exploring the Feasibility of Measures of Strength as a Monitoring Aid in Patients Receiving Case Management
The UK population is ageing and the likelihood of having a long term health condition increases with age. Three out of every five people over 60 in the UK have a long term condition. Ageing and having a long term condition increases the chance of having difficulty being independent and carrying out day to day activities. In recent years the NHS has made a greater effort to prevent these difficulties in patients with long term conditions.
One approach to help patients with long term conditions is case management, where by (usually) a community matron visits patients at home, looking for early warning signs of any worsening of their condition and arranging care and treatment. But the current way this is done varies across the country and hospital admissions are still rising. In order to give the right care at the right time, effective monitoring is needed to help the community matron detect and act on changes in the patient's condition.
Read more
Loss of muscle strength in old age is linked to a poor health, but it is not known whether simple measures of muscle strength could be used to detect and predict declines in health in the short to medium term to help maintain independence and prevent an accident or hospital admission.
The aim of this study is to look at whether monitoring muscle strength in case managed patients is practical, acceptable and useful in detecting when a patient's condition worsens. Each patient will be visited by the researcher in their home twice in the first week, then once every two weeks, for another 5 weeks, to carry out three simple measures of grip and respiratory strength, and complete questionnaires about their health and ability to carry out day to day activities. Each visit will last about 20 to 30 minutes. A small group of clinicians will be asked about their views of the strength measures. Database analysis will allow descriptive data on the patient group to be gathered and analysed.
- Conditions
- Multiple Conditions, Coronary Heart Disease, Diabetes, Hypertension, Chronic Obstructive Pulmonary Disease
- Keywords
- case management, long term conditions, aged sixty five and over
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Hypertension, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case managed patients | Patients aged 65 years and over receiving community case management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
To assess reliability of measure over a one week period and the stability of the measure over 13 weeks, in this patient group, as well as acceptability.
Measured: 13 weeks
Secondary outcomes (3)
Peak expiratory flow
To measure reliability over one week and stability over 13 weeks in this patient group, as well as acceptability.
Measured: 13 weeks
Peak inspiratory flow
To assess reliability over one week, and stability over 13 weeks in this patient group, as well as acceptability.
Measured: 13 weeks
Sickness behaviour scale
To explore the relationship between sickness behaviour and measures of strength.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple ConditionsStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Barnes, University of Southampton
- Investigators
- Nicola Barnes, MPharm, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597882
- Sponsor's protocol ID
- 8550
- Other IDs
- 1409-ERGO
- Status last verified
- Feb 2014
- First submitted
- 10 May 2012
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Targeting of Admission Avoidance Interventions in Older People With Long-term Conditions:An Observational,Longitudinal Study Exploring the Feasibility of Measures of Strength as a Monitoring Aid in Patients Receiving Case Management
- ClinicalTrials.gov ID
- NCT01597882
- Acronym / sponsor ID
- 8550
- Conditions
- Multiple Conditions, Coronary Heart Disease, Diabetes, Hypertension, Chronic Obstructive Pulmonary Disease
- Keywords
- case management, long term conditions, aged sixty five and over
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 May 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 UK population is ageing and the likelihood of having a long term health condition increases with age. Three out of every five people over 60 in the UK have a long term condition. Ageing and having a long term condition increases the chance of having difficulty being independent and carrying out day to day activities. In recent years the NHS has made a greater effort to prevent these difficulties in patients with long term conditions.
One approach to help patients with long term conditions is case management, where by (usually) a community matron visits patients at home, looking for early warning signs of any worsening of their condition and arranging care and treatment. But the current way this is done varies across the country and hospital admissions are still rising. In order to give the right care at the right time, effective monitoring is needed to help the community matron detect and act on changes in the patient's condition.
Loss of muscle strength in old age is linked to a poor health, but it is not known whether simple measures of muscle strength could be used to detect and predict declines in health in the short to medium term to help maintain independence and prevent an accident or hospital admission.
The aim of this study is to look at whether monitoring muscle strength in case managed patients is practical, acceptable and useful in detecting when a patient's condition worsens. Each patient will be visited by the researcher in their home twice in the first week, then once every two weeks, for another 5 weeks, to carry out three simple measures of grip and respiratory strength, and complete questionnaires about their health and ability to carry out day to day activities. Each visit will last about 20 to 30 minutes. A small group of clinicians will be asked about their views of the strength measures. Database analysis will allow descriptive data on the patient group to be gathered and analysed.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case managed patients | – | –Patients aged 65 years and over receiving community case management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients receiving cmmunity health case management.
Key inclusion criteria (1 listed)
- Patients aged 65 years or over receiving health case management in the community.
Key exclusion criteria (9 listed)
- Enrolled in any other research study
- Preclude consent:
- Preclude participation/ collection of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grip strength
Time frame: 13 weeks
To assess reliability of measure over a one week period and the stability of the measure over 13 weeks, in this patient group, as well as acceptability.
3 secondary outcomes
Peak expiratory flow
Time frame: 13 weeks
Peak inspiratory flow
Time frame: 13 weeks
Sickness behaviour scale
Time frame: 13 weeks
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 19 Feb 2014.
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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.
Nicola Barnes, MPharm principal investigator
University of Southampton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Conditions and Coronary Heart Disease, run by University of Southampton at 2 sites in United Kingdom.
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 1 inclusion and 9 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Grip strength (time frame: 13 weeks). 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 19 Feb 2014.