Improving Monitoring of Patients Receiving Case Management

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597882
• Other study ID #: 8550
• Secondary ID: 1409-ERGO
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: February 16, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes
• Disease
• Hypertension
• Lung Diseases, Obstructive
• Multiple Conditions
• Myocardial Ischemia
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Solent NHS Trust	Portsmouth
United Kingdom	Southern Health NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks	No
Secondary	Peak expiratory flow	To measure reliability over one week and stability over 13 weeks in this patient group, as well as acceptability.	13 weeks	No
Secondary	Peak inspiratory flow	To assess reliability over one week, and stability over 13 weeks in this patient group, as well as acceptability.	13 weeks	No
Secondary	Sickness behaviour scale	To explore the relationship between sickness behaviour and measures of strength.	13 weeks	No