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 Hospitals 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 Hospitals 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
Study website
Contact information
Type
Scientific
Contact name
Dr Mathias Barra
ORCID ID
Contact details
Sykehusveien 25
Lørenskog
1478
Norway
+47 (0)40847204
mathias.barra@ahus.no
Additional identifiers
EudraCT/CTIS number
IRAS 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(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.
Study design
Interventional open randomized controlled trial with two study branches
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
01/06/2013
Overall study end date
01/04/2015
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
National government
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 21/09/2016 | Yes | No |