- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02574416
An Evaluation of the Determinants of Lifestyle and Health Behaviors in Later Life (LiLL)
An Evaluation of the Determinants of Lifestyle and Health Behaviours in Later Life, and to Investigate Their Relationship With Health Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be identified by the Medicine for Older People clinician and asked if they would like to speak to a member of the research team. A member of the research team will approach suitable patients and ask them if they wish to participate. Patients will have the opportunity to read and take away a Patient Information Sheet, and also ask questions about the study and what participating in it would involve. Participants in the study will be telephoned to arrange an appointment for a home visit at a convenient time, or an appointment will be made at this first meeting if this is possible. Written informed consent will be taken at the home visit.
Patients who have used the same Medicine for Older People Services in Southampton within the previous year will be known to the medical team. The medical team will write to the patient with a letter of invitation to participate in the study and the Patient Information Sheet. The letter will contain a reply slip and a stamped addressed envelope. It will also contain contact details should the patient wish to talk to someone about the study and what it would mean for them to participate. Patients who send back their reply slip saying that they would like to participate in the study will be contacted to arrange a home visit at a convenient time. If no reply slip is received after two weeks then a member of the research team will telephone the patient once to find out whether they have received the letter and to offer them the opportunity to participate. This will be done sensitively and carefully and the patients' wishes will be respected at all times. Written informed consent will be taken at the time of the home visit.
All participants will be visited at home by a member of the research team who will interview the participant to obtain background sociodemographic information and a series of short questionnaires will be administered. Each participant will have an assessment of diet quality, appetite and physical function. In addition, weight, grip strength and physical performance will be measured. Participants will be free to decline any part of the questionnaire or assessment.
Two and a half years after this interview the investigators will check on the hospital administration system if the participant's contact details have changed or if they have died since the initial visit. The investigators will then contact the participant by phone (having gained permission to do this at the original assessment visit) to arrange a home visit when diet quality, appetite and physical function will be reassessed. The investigators' experience from the Southampton Mealtime Assistance Study of contacting older study participants by telephone has shown this to be an effective way of ascertaining if the participant is interested in continuing with the study or would prefer not to. The participant will be given the opportunity to refuse a visit with no pressure applied. At the visit the investigators will also ask about the participants' use of the key community services over the past year. The investigators will also ask permission to access the patient's medical records to obtain details of hospital admissions or outpatient appointments in the intervening year.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 6YD
- MRC Lifecourse Epidemiology Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any person who has attended a Medicine for Older People Service run by Southampton General Hospital between February 2014 and August 2016.
Exclusion Criteria:
- Unable to give informed consent
- acutely unwell
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary quality
Time Frame: 2.5 years
|
Diet quality, which will be assessed by deriving the participants' prudent diet score from the 20-item Food Frequency Questionnaire.
|
2.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function
Time Frame: 2.5 years
|
Physical function which will be assessed by asking ten questions from the Short Form - 36 which ask whether the participants' health limits them from carrying out certain daily activities.
|
2.5 years
|
Grip strength
Time Frame: 2.5 years
|
Measuring using a Jamar dynamometer
|
2.5 years
|
Timed up and go
Time Frame: 2.5 years
|
Time taken to rise from a chair, walk 3m and then return to the chair and sit down.
|
2.5 years
|
3m walk
Time Frame: 2.5 years
|
Time taken to walk 3m
|
2.5 years
|
Timed chair rise
Time Frame: 2.5 years
|
Time taken to stand up and sit down again five times
|
2.5 years
|
Mortality
Time Frame: At 1 year and 2.5 years follow up
|
Mortality data will be taken from hospital records
|
At 1 year and 2.5 years follow up
|
Number of hospital admissions
Time Frame: At one year follow up
|
Number of hospital admissions will be abstracted from hospital records
|
At one year follow up
|
New diagnoses
Time Frame: At one year follow up
|
New diagnoses will be taken from hospital records
|
At one year follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sian Robinson, PhD, National Health Service, United Kingdom
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RHM MED 1215
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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