Condition category
Circulatory System
Date applied
21/05/2013
Date assigned
30/06/2014
Last edited
23/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent studies do no not provide sufficient information on how to increase response rates in patients. This study is currently in the middle of a large data-collection phase and over the next year will send postal 12-month follow-up questionnaires to patients who have been discharged from the Akershus University Hospital’s stroke unit (SU). These patients have already received 3-month follow-up questionnaires. Several patients have already been pre-selected to be contacted by telephone; those are the patients for whom we have available a primary care-giver (relative or other), and who are either above 80 years of age, or who were discharged to some address other than their home address (i.e. a rehabilitation facility). In this study, we aim to find out if contacting the remaining patients by telephone before sending out the questionnaires can increase response rates.

Who can participate?
Patients who have not previously been contacted or who did not fill in or receive the questionnaire can take part.

What does the study involve?
The patients are randomly allocated to one of two groups. The intervention group will be pre-contacted by telephone about 1 week before we mail them the questionnaire; the control group patients will simply receive a questionnaire by mail without being pre-contacted. All patients will receive a 12-month follow-up questionnaire by mail. The intervention group patients will be contacted by telephone before shipment.

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

Where is the study run from?
Akershus University Hospital’s Health Services Research Center (HØKH), Norway.

When is study starting and how long is it expected to run for?
The study started in June 2013 and ended in April 2014.

Who is funding the study?
The Research Council of Norway (Norway).

Who is the main contact?
Dr Mathias Barra
mathias.barra@ahus.no

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mathias Barra

ORCID ID

Contact details

Sykehusveien 25
Lørenskog
1478
Norway
+47 (0)40847204
mathias.barra@ahus.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Contacting by telephone prior to dispatching postal questionnaires increases response rates in a senescent and frail patient population: an open randomized controlled trial

Acronym

Study hypothesis

To determine whether contacting by telephone prior to dispatching postal questionnaires can increase response rates in a senescent and frail patient population.

Ethics approval

Ethics approval not required: The NOR-SPOT project has been submitted to a regional ethics committee for medical research, and exempted from evaluation because the study hypotheses were not directly related to health and illness.
Under Norwegian law it is therefore sufficient that the project, as it has been, is approved by the hospital's internal privacy ombudsman. Randi Otterstad (randi.otterstad@ahus.no); Ref: 11.076.

Study design

Interventional open randomized controlled trial with two study branches

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Response rate to postal questionnarie targeting stroke patients

Intervention

The telephone pre-contact intervention will be performed according to the following procedure:
1. Three attempts will be made to contact the subjects on their mobile phone (land-line when no mobile-number is available). If contact is established during one of these three attempts, or on a call-back the caller will aim at achieving what we call as an informal consent to shipping. This means that the caller will aim at having the participant agree to receive the questionnaire for their review.
2. The caller may answer questions about the survey, but should remain neutral
3. Any house-hold member can act as proxy for the participant e.g., a spouse or other family member answering the phone
4. Where a prior written consent to participation (given at the SU) exists, the caller reminds the participant of this fact. However, the caller must not induce guilt for not having responded to the 3-month shipment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Response rate: the total number of responders who responded within 45 days of shipping out.

Secondary outcome measures

Final response rate: the total number of responders who responded after 365 days.

The intervention (pre-contact by telephone) will be undertaken between June 1st 2013 and April 1st 2014, but that the second outcome “response rates within 356 days” will (necessarily) be recorded on April 1st 2015.

Overall trial start date

01/06/2013

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

We will include NOR-SPOT patients who:
1. Have not previously been contacted
2. Have not returned the 3-month questionnaire or did not receive the questionnaire
3. Who are not pre-selected for pre-contact: viz. those who were discharged to their own home, under the age of 80, or those with a spouse or other relative living at their home address
4. Has a phone number for contact
5. Have a confirmed stroke diagnosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Patients will be excluded when it is discovered that the patient is no longer alive within 7 days after dispatch of the questionnaire. This goes for participants both in the control and the intervention groups.

Recruitment start date

01/06/2013

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Norway

Trial participating centre

Sykehusveien 25
Lørenskog
1478
Norway

Sponsor information

Organisation

Akershus University Hospital (Norway)

Sponsor details

Sykehusveien 25
Lørenskog
1478
Norway
-
mathias.barra@ahus.no

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Norges Forskningsråd

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Results and Publications

Publication and dissemination plan

We are planning to publish the results in April 2015

Intention to publish date

01/04/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27654008

Publication citations

Additional files

Editorial Notes

22/09/2016: Publication reference added. The registration was initiated on 21/05/2013 and finalised on 30/06/2014. Following the prospective submission in May 2013, there were no subsequent changes to the protocol. The recruitment started on 01/06/13, after initiation of public registration.