Contacting by telephone prior to dispatching postal questionnaires increases response rates in a senescent and frail patient population

ISRCTN ISRCTN31304930
DOI https://doi.org/10.1186/ISRCTN31304930
Secondary identifying numbers N/A
Submission date
21/05/2013
Registration date
30/06/2014
Last edited
23/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Dr Mathias Barra
Scientific

Sykehusveien 25
Lørenskog
1478
Norway

Phone +47 (0)40847204
Email mathias.barra@ahus.no

Study information

Study designInterventional open randomized controlled trial with two study branches
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleContacting by telephone prior to dispatching postal questionnaires increases response rates in a senescent and frail patient population: an open randomized controlled trial
Study hypothesisTo determine whether contacting by telephone prior to dispatching postal questionnaires can increase response rates in a senescent and frail patient population.
Ethics approval(s)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.
ConditionResponse rate to postal questionnarie targeting stroke patients
InterventionThe 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 typeOther
Primary outcome measureResponse rate: the total number of responders who responded within 45 days of shipping out.
Secondary outcome measuresFinal 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 study start date01/06/2013
Overall study end date01/04/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Participant inclusion criteriaWe 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 exclusion criteriaPatients 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 date01/06/2013
Recruitment end date01/04/2014

Locations

Countries of recruitment

  • Norway

Study participating centre

Sykehusveien 25
Lørenskog
1478
Norway

Sponsor information

Akershus University Hospital (Norway)
Hospital/treatment centre

Sykehusveien 25
Lørenskog
1478
Norway

Email mathias.barra@ahus.no
ROR logo "ROR" https://ror.org/0331wat71

Funders

Funder type

Government

Norges Forskningsråd
Government organisation / National government
Alternative name(s)
Forskningsrådet, Norwegian Research Council, Research Council of Norway
Location
Norway

Results and Publications

Intention to publish date01/04/2015
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planWe are planning to publish the results in April 2015
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/09/2016 Yes No

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.