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
| ISRCTN | ISRCTN11166046 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11166046 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/06/2014
- Registration date
- 25/06/2014
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
This study aims to improve preventive care and medical education in older people. The main objective of this study is to evaluate health risks of people 65 years of age and older, and the potential benefits of using the Health Risk Appraisal for Older People (HRA-O) standardized questionnaire in clinical practice in developing counselling sessions tailored to individual health and lifestyle needs to improve their general health and wellbeing.
Who can participate?
People 65 years of age and older and who meet the following criteria are eligible for this study: live in Bucharest or within 2 to 4 hours travel time, speak/understand Romanian language, do not live in a nursing home, do not have severe dementia, do not have severe disability, do not have a terminal illness, and have not had major surgery in the last 3 months.
What does the study involve?
The study takes place over a period of 8 months. Participants are randomly allocated into one of two groups. Group 1 (intervention group) receive monthly specialised counselling guided by individual Health Reports. Group 2 (control group) receive their usual care. In addition, everyone is asked to complete a Brief Questionnaire answering questions about health measurements, medical history and functioning. They are also asked to complete a complementary HRA-O questionnaire, answering questions, for example, about their diet habits, physical activity, social network at the start of the study and then 6 months later. Data on subjects name, sex, contact details, education level, living arrangements, marital status, income, body weight, height, blood pressure and current medication is also recorded. At the end of the study, people in the intervention group are asked to complete a feedback questionnaire, answering questions about their experience being part of this study.
What are the possible benefits and risks of participating?
There is no relevant benefit or risk related to taking part in the study for participants.
Where is the study run from?
This research project takes place at the National Institute of Gerontology and Geriatrics Ana Aslan, Bucharest, Romania. The study takes place in both hospital and out-patient clinic settings.
When is the study starting and how long is it expected to run for?
May 2014 to June 2015
Who is funding the study?
University of Geriatrics, Berne, Switzerland
Who is the main contact?
Dr Anna Marie Herghelegiu
anaherghelegiu@yahoo.com
Contact information
Scientific
National Institute of Geriatrics and Gerontology "Ana Aslan"
Str. Caldarusani nr. 9, sector 1
Bucharest
011241
Romania
Study information
| 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) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | RAHEO |
| Study hypothesis | The main hypotheses that are tested in this randomized controlled study are: 1. Is it feasible to implement a preventive intervention consisting of a standardized health risk appraisal questionnaire (HRA-O) with follow-up counselling in a Romanian setting (e.g. acceptance by older patients)? 2. Does this preventive intervention, over a period of six months, improve intermediate outcomes (e.g. adherence to favorable health behaviors, use of recommended preventive services) among older persons? |
| Ethics approval(s) | Research Ethics Committee of the National Institute of Gerontology and Geriatrics Ana Aslan, Bucharest, Romania, 28/01/2014, ref. 972 |
| Condition | Health and well being/prevention/older people/geriatrics |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 1. Survival 2. Detailed analysis of preventive care process (e.g., blood pressure control, medication use) |
| Overall study start date | 20/05/2014 |
| Overall study end date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | The target total recruitment number of participants is 400 (approximately 200 per site). |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/05/2014 |
| Recruitment end date | 30/06/2015 |
Locations
Countries of recruitment
- Romania
Study participating centre
011241
Romania
Sponsor information
Hospital/treatment centre
Bern University Hospital
Department of Geriatrics
Inselspital
Freiburgstr. 3
Postfach 20
Bern
CH-3010
Switzerland
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Universität Bern, Université de Berne, Universitas Bernensis, UniBE, جامعة برن, Бернскі ўніверсітэт, Бернски университет, Universitat de Berna, Bernská univerzita, Πανεπιστήμιο της Βέρνης, Universitato de Berno, Universidad de Berna, Berni Ülikool, Bernako Unibertsitatea, دانشگاه برن, Bernin yliopisto, Univèrsitât de Bèrna, Universidade de Berna, אוניברסיטת ברן, Università di Berna, ベルン大学, Берн университеті, 베른 대학교, Berno universitetas, Universiteit van Bern, Universitetet i Bern, Бернский университет, Bern Üniversitesi, Берн университеты, Бернський університет, 伯尔尼大学, UB
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/07/2017 | Yes | No |
Editorial Notes
19/10/2017: Publication reference added.
