Condition category
Not Applicable
Date applied
17/06/2014
Date assigned
25/06/2014
Last edited
25/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gabriel loan Prada

ORCID ID

Contact details

National Institute of Geriatrics and Gerontology "Ana Aslan"
Str. Caldarusani nr. 9
sector 1
Bucharest
011241
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

Research Ethics Committee of the National Institute of Gerontology and Geriatrics “Ana Aslan”, Bucharest, Romania, 28/01/2014, ref. 972

Study design

This is an 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

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

20/05/2014

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

The target total recruitment number of participants is 400 (approximately 200 per site).

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

Trial participating centre

National Institute of Geriatrics and Gerontology "Ana Aslan"
Bucharest
011241
Romania

Sponsor information

Organisation

Forschungsfonds Geriatrie (Switzerland)

Sponsor details

Bern University Hospital
Department of Geriatrics
Inselspital
Freiburgstr. 3
Postfach 20
Bern
CH-3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Bern, Bern (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes