An observational study in Health Behavior, Motivation and Health Care Utilization, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Lesotho. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by University Hospital, Basel, Switzerland · Observational
The primary research objective is to examine how uncertainty towards a new medical treatment changes in patients when a partner (can be any close other, i.e. romantic partner, family member, or a close friend) supports the new treatment choice and is willing to be involved in the patient's treatment. I hypothesize that when the patients know that their partner supports uptake of the new medical treatment and will physically accompany them to the visit, patients will (1) experience lower levels of uncertainty and (2) report a higher likelihood of participating in a new treatment in the future, as compared to patients who face the decision about the new treatment alone.
Host trial: Uncertainty survey experiment
This study uses a survey experiment with a hypothetical scenario (vignette) to test the concept of uncertainty and the impact of partner involvement in a hypothetical new medical treatment in patients seeking healthcare in the Butha Buthe district hospital. Specifically, this host trial will be a single-blinded randomized survey experimental design. This means that there will be two versions of the vignette and participants will be randomly given only one version (1:1 allocation). The participants will not be made aware that there is a different version of the vignette but the researchers will be aware of which version the participant receives. The difference between the vignettes (called behavioral manipulation) is whether or not the partner endorses the hypothetical new medical treatment related to the patient's current illness. See the Study measures Section for the specific vignettes.
Study Within a Trial (SWAT): Impact of the researcher's attire on recruitment rates
Within the host trial, the nested study on researcher's attire will take place as a "Study Within A Trial" or SWAT. SWAT is an increasingly recognized method of research that aims to improve the research methodology within an existing trial. The SWAT on researcher attire will take place in the recruitment phase of the host experiment with day-based cluster randomization between white coat versus casual attire assignment. These attire assignments will be given along with the given week's recruitment assignments to the two Basotho research assistants who will work on the host trial. The nested study does not impact the procedures of the survey experiment. Researcher's attire during recruitment will remain the same throughout the survey delivery until the end of the participant's study visit.
308 studies on the registry are indexed under Patient Acceptance of Health Care; 53 are open to participants now.
This study's enrollment of 475 is below the median of 583 across 80 observational studies indexed under Patient Acceptance of Health Care.
Browse Patient Acceptance of Health Care studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Compared within Patient Acceptance of Health Care, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Health Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives a vignette with partner support component before answering AA-Med response items.
Behavioral: Partner support
Receives a vignette without partner support component before answering AA-Med response items.
Behavioral: Without Partner support
Recruited by staff wearing casual attire.
Behavioral: Casual recruiter attire
Recruited by staff wearing formal (clinical) attire
Behavioral: Formal recruiter attire
The intervention group's survey vignette will include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.
The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed. FORMAL dress code of the recruiter is the intervention in this case, defined as clinical attire alluding to some clinical authority.
The intervention group's survey vignette will NOT include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.
The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed. CASUAL dress code of the recruiter is the intervention in this case.
AA-Med score
Ambiguity aversion score difference between two survey groups; AA-Med contains 6 response items, each scored from 1 to 4 (1=disagree completely; 4=agree completely)
Time frame: 1 time measurement immediately after intervention
Recruitment rate
Recruitment success rate (fully participated/ approached) difference between two recruitment attire groups
Time frame: 1 time measurement immediately after intervention
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest. Data shared will be completely anonymized. Study components, aggregate data and results will be disseminated on OSF. Any additional data sharing is subject to approval of the request and execution of all applicable agreements (i.e. a material transfer agreement).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Starting six months after completion of data collection for up to 24 months thereafter.
Access criteria: Independent researchers with academic interest.
Data sharing details ↗ · osf.io
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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