Condition category
Circulatory System
Date applied
02/07/2014
Date assigned
14/08/2014
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to find out how being able to choose how they participate (i.e. the participation mode) effects how many people do participate in a social network study on health-related information. We want to know which participation modes are the most popular and whether these can be improved to encourage more people to take part. Here, we investigate how many people able to choose their participation mode (a telephone interview or postal questionnaire) do take part in the survey compared with those that are offered only one participation mode.

Who can participate?
Adults (18 or older) at high risk for cardiovascular disease (CVD) or with established CVD.

What does the study involve?
The study involves two randomized controlled trials. This means that, for each trial, participants are randomly allocated to either receive an invitation to take part in the social network study with the option to choose their preferred participation mode or a similar invitation but with only one participation mode available. In trial 1, the number of people who choose to take part having been given the option of two participation modes is compared to the number that choose to take part having only been given the option of a telephone interview. In trial 2, the number of people who choose to take part having been given the option of two participation modes is compared to the number that choose to take part having only been given the option of a postal questionnaire.

What are the possible benefits and risks of participating?
There are no immediate benefits or risk for participants.

Where is the study run from?
The Scientific Institute for Quality of Healthcare, Radboud University Medical Centre Nijmegen (Netherlands)

When is study starting and how long is it expected to run for?
June 2013 to March 2014.

Who is funding the study?
The European Union Seventh Framework Programme (FP7) (Belgium)

Who is the main contact?
Professor Michel Wensing
Michel.Wensing@radboudumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michel Wensing

ORCID ID

Contact details

Geert Grooteplein 21
Nijmegen
6525 EZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving participation rates by providing choice on participation mode: Randomized controlled trials.

Acronym

Study hypothesis

It is hypothesised that participation rates will be higher when respondents can choose their preferred participation mode compared to when no choice on participation mode is provided.

Ethics approval

Ethics approval not required.

The study protocol and its materials (e.g. questionnaires and letters) were submitted to the Medical Ethical Committee of Radboud University Medical Centre Nijmegen. This committee assessed that the Dutch law for medical scientific research does not apply to this research. As the research does not involve testing of body materials, it was decided that no approval was required from a local medical ethical committee as well.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Patients at high risk for cardiovascular disease and with established cardiovascular disease.

Intervention

This study is part of the ‘Tailored Implementation for Chronic Diseases’ (TICD) project and is integrated in a program evaluation which has been designed as a two arm randomized controlled trial (NTR4069). For purposes of the program evaluation, patients received a questionnaire booklet containing mainly questions on health-related lifestyle. For purposes of the randomized controlled trials of participation rates, different invitations were included at the last page of the questionnaire booklet to invite patients for participation in a social network study on health-related information sharing. For determining whether providing choice on participation mode improved participation rates, patients were randomly allocated to receive one of two formats of invitations. On the choice format invitations, patients could indicate whether they wanted to participate in the network study by:
1. A telephone interview or
2. A postal questionnaire.
On the single format invitation, only one participation mode was offered. Invitations were varied over two trials.
Trial 1: Participation rates are compared of patients who received a choice format invitation with that of patients who received a single format invitation to participate by a telephone interview.
Trial 2: Participation rates are compared of patients who received the choice format invitations with that of patients who received a single format invitation to participate by a postal questionnaire.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participation rate, defined as the percentage of patients who actually participated in the social networks study. That is the total number of patients who had completed an interview or questionnaire for the social networks study divided by the total number of participants in the program evaluation.

Secondary outcome measures

1. Conditional participation rate: Defined as the total number of patients who had completed an interview or questionnaire for the social networks study divided by the total number of patients willing to participate in the study.
2. Willingness to participate: Defined as the percentage of patients initially willing to participate in the social network study. That is the total number of patients willing to participate divided by the number of participants in the program evaluation.

The response trials are embedded within a program evaluation which has been designed as a two-arm randomized controlled trial. For this program evaluation, questionnaires containing invitations for the response trials were send at baseline of the program. Willingness to participate and preference for participation mode, were measured up to 2 months after sending questionnaires with invitations. We planned to perform interviews and send questionnaires on behalf of the social networks study within two months after receipt of completed invitations.

Overall trial start date

01/06/2013

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with high risk for CVD and established CVD
2. Adults aged 18 or older and who are capable of providing informed consent
3. Patients with high risk for CVD have a risk score of 20% or higher on 10-years-morbidity and mortality due to CVD
International Classifications of Primary care (ICPC) codes were used to extract eligible patients from medical records from general practices.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

338 in each of two performed trials

Participant exclusion criteria

1. Diabetes mellitus
2. Pregnancy and lactation
3. Terminal illness
4. Cognitive impairments
5. Poor language skills

Recruitment start date

01/06/2013

Recruitment end date

31/03/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Geert Grooteplein 21
Nijmegen
6525 EZ
Netherlands

Sponsor information

Organisation

Scientific Institute for Quality of Healthcare (IQ healthcare) (Netherlands)

Sponsor details

Radboud University Medical Centre Nijmegen
Geert Grooteplein 21
Nijmegen
6525 EZ
Netherlands

Sponsor type

University/education

Website

http://www.iqhealthcare.nl/

Funders

Funder type

Government

Funder name

European Union Seventh Framework Programme (FP7) within the theme HEALTH.2013.3.1-1 under grant agreement no 258837 (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ZonMw (The Netherlands Organisation for Health Research and Development) project no 200310011.(Netherlands)

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