The medical Risk Assessment and Health Education in Older people (RAHEO) study: Feasibility and performance of a health risk appraisal questionnaire combined with health education in Romania

• Register: ISRCTN
• Last refreshed on: 20 November 2017
• Main ID: ISRCTN11166046
• Date of registration: 25/06/2014
• Prospective Registration: No
• Primary sponsor: Forschungsfonds Geriatrie (Switzerland)
• Public title: The medical Risk Assessment and Health Education in Older people (RAHEO) study: Feasibility and performance of a health risk appraisal questionnaire combined with health education in Romania
• Scientific title: The medical risk assessment and health education in older people (RAHEO) study: A randomized controlled study to evaluate the feasibility and intermediate effects of a preventive intervention (health risk appraisal questionnaire with follow-up counselling) compared to usual care in older patients in Romania
• Date of first enrolment: 20/05/2014
• Target sample size: 400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11166046
• Study type: Interventional
• Study design: Interventional single-blinded randomized controlled clinical trial. Trial is single-center, conducted at two sites of this center (one site: inpatient, one site: outpatient) (Prevention)
• Phase: Not Applicable

Countries of recruitment

Romania

Contacts

• Name: Gabriel loan Prada

Key inclusion & exclusion criteria

Inclusion criteria: Site 1: Subjects 65 years of age and older, both male and female admitted to ambulatory geriatric care of the National Institute of Gerontology and Geriatrics ?Ana Aslan?, Bucharest, Romania, during the study recruitment period
Site 2: Subjects 65 years of age and older, both male and female admitted to inpatient geriatric care of the National Institute of Gerontology and Geriatrics ?Ana Aslan?, Bucharest Romania, during the study recruitment period
Exclusion criteria: 1. Moderate to severe dementia
2. Severe disability - needs human help in one or more basic activities of daily living
3. Has terminal illness
4. Has had major surgery within the last 3 months
5. Does not live in catchment area - Bucharest and within 2 to 4 hours travel time
6. Lives in nursing home
7. Does not speak/understand Romanian language
8. Inability or unwillingness to complete the self-administered questionnaires
9. Person unwilling to give informed consent

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Health and well being/prevention/older people/geriatrics
Not Applicable

Intervention(s)

Test group - Individualized, specialized medical counselling guided by health reports generated based on the Health Risk Appraisal for Older people (HRA-O) standardized questionnaire
Control group ? no counselling

Primary Outcome(s)

Outcome measures for evaluating the feasibility (based on abstraction of recruitment phase, and feed-back in intervention group):
1. Number of patients excluded due to inability or unwillingness to complete the self-administered questionnaires or unwillingness to give informed consent
2. Structured feed-back from participating older persons at start and at end of intervention period
3. Base-line prevalence of identified risks

Outcomes (based on comparisons between persons in intervention and control groups, and pre-post comparisons in intervention group):
1. Adherence to recommended health behaviors (self-report) at six-month follow-up
2. Intention to change health behavior (self-report) at six-month follow-up
3. Health status and status of preventive care (self-report, and objective clinical data) in surviving older persons at six-month follow-up

Secondary Outcome(s)

1. Survival
2. Detailed analysis of preventive care process (e.g., blood pressure control, medication use)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Universität Bern