Condition or disease |
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Frail Elderly |
Study Type : | Observational |
Actual Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Assessment of Frailty in Elderly People With Ischemic Heart Disease Being Considered for Revascularisation. |
Actual Study Start Date : | July 2016 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | December 2020 |
Group/Cohort |
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Frailty status
Frailty status will be determined by prespecified assessment tools in the study protocol. These assessment tools will be Fried Frailty phenotype model and edmonton frailty Scale.
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Ages Eligible for Study: | 80 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Aged 80 years and above and either
Exclusion Criteria:
Patients will be excluded from the study in the event of any of the following:
United Kingdom | |
Castle Hill Hospital | |
Cottingham, East Riding Of Yorkshire NHS Trust, United Kingdom, HU16 5JQ |
Principal Investigator: | Angela Hoye, MB.ChB,PhD | Hull and East Yorkshire NHS Trust |
Tracking Information | |||||
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First Submitted Date | October 11, 2016 | ||||
First Posted Date | July 15, 2019 | ||||
Last Update Posted Date | July 15, 2019 | ||||
Actual Study Start Date | July 2016 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Change in Quality Of Life Questionnaire [ Time Frame: baseline and 3, 9 and 24 months ] The primary out come will be quality of life assessed by SF-12 survey forms
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Assessing Frailty in Elderly Patients Who Have Ischemic Heart Disease | ||||
Official Title | Assessment of Frailty in Elderly People With Ischemic Heart Disease Being Considered for Revascularisation. | ||||
Brief Summary | Participants aged 80 years or over, who attend Castle Hill Hospital with either stable angina or an acute coronary syndrome will be invited to participate in the study. After induction into the study, these participants will be assessed for frailty and quality of life (QoL) using predetermined assessment tools. Quality of life (QoL) will be assessed using the standardised SF-12 questionnaire proforma. Frailty assessment will be based on the use of the Fried Frailty Phenotype criteria and the Edmonton Frailty Scale. Patients will be reassessed at 3,9 and 24 months for their clinical outcomes, repeat frailty assessment and quality of life. | ||||
Detailed Description |
STUDY SETTINGS: Cardiology and cardiothoracic out-patients and in-patient wards of Castle Hill hospital SAMPLE SIZE CALCULATION: FRAIL-HEART is a preliminary observational study designed to evaluate the practicality of undertaking frailty assessments in this population. The sample size of n=150 is estimated on the basis of feasibility. Investigators aim to recruit all consecutive patients who attend our department over a 1 year period. With an expected drop-out rate of 10% , investigators anticipate that it will be feasible to enrol 150 patients in the required time-frame. PARTICIPANTS: The study target population will be patients aged 80 years or more, who are admitted or referred to the cardiology department because of underlying coronary artery disease. IDENTIFICATION & RECRUITMENT: These participants will be recruited into the study from outpatient cardiology clinics and from identification of suitable inpatients admitted to the cardiology and cardiothoracic units. BASELINE ASSESSMENT: The baseline assessment will include gathering patient baseline demographic data, current diagnosis and clinical status, assessment of the comorbid conditions, and information regarding relevant investigation results including blood results, electrocardiogram (ECG), echocardiogram and coronary angiography data. Participants will be asked to complete QoL questionnaire and undergo the frailty assessments. This will entail completion of several questionnaires. SF-12 QoL QUESTIONNAIRE: This questionnaire of 12 questions have been extensively used in research practice and validated to assess QoL in a variety of clinical settings20. FRAILTY ASSESSMENT: This will be evaluated using both the Fried phenotype and Edmonton frailty scale. Study participants will first be asked to complete the written questionnaires. They will then have a measure of handgrip strength and if feasible will be asked to do 'get up and go' and 'five metre walk 'test as detailed in the Edmonton and Fried assessments respectively. Participants who are unable to walk will be marked as per the criteria. Where applicable, participants will be allowed to use walking aids as required. Where applicable, the research team will also evaluate the results of coronary angiography and will undertake both SYNTAX as well as EUROSCORE calculations. FOLLOW UP ASSESSMENTS: The study participants will be seen at 3, 9 and 24 month intervals and will be asked to complete the QoL questionnaire and undergo frailty assessment. The following variables will be recorded at each follow-up visit.
DEATHS DURING THE STUDY PERIOD: Due to the advanced age of the study participants, it is expected that some patients might die during the study period. In such a situation the data already gathered will be retained in the study. Investigators will be advised to check on the Hull and East Yorkshire NHS Trust record systems before sending out any follow up appointments. The participant's family and relatives will not be approached after their death. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | All patients (male and female) aged 80 and over and who have a primary diagnosis of ischaemic heart disease will be eligible for participation in the study. | ||||
Condition | Frail Elderly | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Frailty status
Frailty status will be determined by prespecified assessment tools in the study protocol. These assessment tools will be Fried Frailty phenotype model and edmonton frailty Scale.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
150 | ||||
Original Actual Enrollment | Same as current | ||||
Estimated Study Completion Date | December 2020 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria: Aged 80 years and above and either
Exclusion Criteria: Patients will be excluded from the study in the event of any of the following:
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Sex/Gender |
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Ages | 80 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04019405 | ||||
Other Study ID Numbers | 193997 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Hull University Teaching Hospitals NHS Trust | ||||
Study Sponsor | Hull University Teaching Hospitals NHS Trust | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Hull University Teaching Hospitals NHS Trust | ||||
Verification Date | July 2019 |