Improving Monitoring of Patients Receiving Case Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicola Barnes, University of Southampton
ClinicalTrials.gov Identifier:
NCT01597882
First received: May 10, 2012
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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.


Condition
Multiple Conditions
Coronary Heart Disease
Diabetes
Hypertension
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Grip strength [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Peak expiratory flow [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    To measure reliability over one week and stability over 13 weeks in this patient group, as well as acceptability.

  • Peak inspiratory flow [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    To assess reliability over one week, and stability over 13 weeks in this patient group, as well as acceptability.

  • Sickness behaviour scale [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    To explore the relationship between sickness behaviour and measures of strength.


Enrollment: 114
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case managed patients
Patients aged 65 years and over receiving community case management.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving cmmunity health case management.

Criteria

Inclusion Criteria:

  • Patients aged 65 years or over receiving health case management in the community.

Exclusion Criteria:

  1. Enrolled in any other research study
  2. Preclude consent:

    • Significant cognitive impairment resulting in lack of capacity to consent. b. Unable to communicate without significant aids e.g. Non-English speaking.
  3. Preclude participation/ collection of data

    • Significant emotional distress or psychotic illness active within the last 6 months.
    • Receiving end of life care.
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597882

Locations
United Kingdom
Solent NHS Trust
Portsmouth, United Kingdom, PO4 8LD
Southern Health NHS Foundation Trust
Southampton, United Kingdom, PO13 0FH
Sponsors and Collaborators
University of Southampton
Investigators
Principal Investigator: Nicola Barnes, MPharm University of Southampton
  More Information

No publications provided

Responsible Party: Nicola Barnes, Post-graduate Research Student, University of Southampton
ClinicalTrials.gov Identifier: NCT01597882     History of Changes
Other Study ID Numbers: 8550, 1409-ERGO
Study First Received: May 10, 2012
Last Updated: February 16, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Southampton:
case management
long term conditions
aged sixty five and over

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypertension
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014