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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00005502 |
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Date of registration:
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03/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cognitive impairments in patients enrolled in cardiac rehabilitation (CR): prevalence and impact on the success of rehabilitation and return to work
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Scientific title:
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Cognitive impairments in patients enrolled in cardiac rehabilitation (CR): prevalence and impact on the success of rehabilitation and return to work - CoCaRehab |
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Date of first enrolment:
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18/08/2014 |
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Target sample size:
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500 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00005502 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: screening
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Annett
Salzwedel |
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Address:
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Am Neuen Palais 10, Haus 12
14469
Potsdam
Germany |
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Telephone:
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0331-977-4061 |
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Email:
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annett.salzwedel@uni-potsdam.de |
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Affiliation:
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Universität PotsdamProfessur für Rehabilitationswissenschaften |
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Name:
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Annett
Salzwedel |
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Address:
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Am Neuen Palais 10, Haus 12
14469
Potsdam
Germany |
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Telephone:
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0331-977-4061 |
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Email:
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annett.salzwedel@uni-potsdam.de |
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Affiliation:
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Universität PotsdamProfessur für Rehabilitationswissenschaften |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with coronary heart disease (CHD) who are insured by the German statutory pension insurance scheme will be included.
Exclusion criteria: - intensive care treatment
- referral back to hospital
- infectious disease (inability to participate in patient education)
Age minimum:
18 Years
Age maximum:
67 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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F06.7
I25
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F06.7
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Chronic ischaemic heart disease
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Mild cognitive disorder
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Intervention(s)
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Group 1: All patients enrolled in this study will participate in the standard education program offered during CR. At discharge from CR, the effect of mild cognitive impairment on the outcome of patient education will be tested statistically, comparing patients with and without cognitive impairments. This comparison will consider the impact of cognitive impairments that were prevalent in patients at the start and end of CR.
Mild cognitive impairment will be assessed according to the original version of the Montreal Cognitive Assessment (MoCA) at the beginning and by its parallel version at the end of CR.
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Primary Outcome(s)
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Primary outcome is the proportion of patients with mild cognitive impairment, as defined by a cut-off score of the MoCA. While the original version of the MoCA will be employed at admission to rehabilitation, an official parallel version will be used at discharge to explore whether the degree of impairment has changed during CR (see section secondary outcome).
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Secondary Outcome(s)
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Patients with and without cognitive impairment at the beginning of CR will be analysed in respect of:
- the success of rehabilitation at the end of CR and 6 months later,
- the proportion of patients returned to work and
- their cognitive ability at discharge (official parallel version of the MoCA).
The success of CR will be evaluated considering the change in knowledge gained through patient education during CR. This increase in knowledge is expected to be associated with patients' cognitive ability.
In the questionnaire employed to assess patients’ knowledge, correct answers will be counted and summed up to give a score ranging from 0 to 34 points. No point will be given for wrong answers.
This questionnaire will be employed at the start and end of CR as well as in the follow-up (6 months later). In addition, patients’ ability to use the knowledge attained to live a healthy life will be examined in the follow-up. Likewise, occupational reintegration will be evaluated analysing the proportion of patients returned to work with regard to cognitive impairment.
Emerging significant differences in the success of CR between impaired and non-impaired patients, as demonstrated by patients’ learning progress, a respective change in life style and return to work, would indicate specific social and psychological needs during and beyond inpatient CR.
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Source(s) of Monetary Support
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Deutsche Rentenversicherung Bund
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Universität Potsdam
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Ethics review
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Status: Approved
Approval date: 13/05/2014
Contact:
Ethikkommission der Universität Potsdam
+49 3 31 9 77 17 91
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