Improving participation rates by providing choice on participation mode

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN89237105
• Date of registration: 14/08/2014
• Prospective Registration: No
• Primary sponsor: Scientific Institute for Quality of Healthcare (IQ healthcare) (Netherlands)
• Public title: Improving participation rates by providing choice on participation mode
• Scientific title: Improving participation rates by providing choice on participation mode: Randomized controlled trials.
• Date of first enrolment: 01/06/2013
• Target sample size: 338
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN89237105
• Study type: Interventional
• Study design: Randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Michel Wensing

Key inclusion & exclusion criteria

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.

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

European Union Seventh Framework Programme (FP7) within the theme HEALTH.2013.3.1-1 under grant agreement no 258837 (Belgium), ZonMw (The Netherlands Organisation for Health Research and Development) project no 200310011.(Netherlands)

Ethics review

Status:
Approval date:
Contact:

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.

Results

• Results available: Yes
• Date Completed: 31/03/2014