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Health BehaviorIROHLANCT02502292

Innovative Policies for Healthy Aging

A study testing Fotonovela in people with Health Behavior and Attitude to Health, run by Jacobs University Bremen gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators evaluate an intervention aiming to increase participation and communication of older adults during primary care consultations with their General Practitioner(GP). The investigators are particularly interested in a Photo novel tool with this aim. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
What is being tested?
Fotonovela
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteGermany
Study dates
Jul 2015to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Areas indicative of limited or marginal health literacy
  • Carry out in a neutral setting

Who cannot join

  • Eye-sight or hearing disabled people. This is because this study requires participants have the ability to read and watch and listen to videos.

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Jacobs University Bremen gGmbH

    Bremen, 28759

Other trials in Germany

About this study

Official title: Sustainable Health Systems Through Health Literacy for Healthy Aging

In this study, the investigators evaluate an intervention aiming to increase participation and communication of older adults during primary care consultations with their General Practitioner(GP). The investigators are particularly interested in a Photo novel tool with this aim. Photo novels are picture stories, which have the advantage of using a familiar narrative format, thereby possibly increasing comprehension, personal involvement and motivation and self-efficacy to perform the relevant behaviors by offering role models (story characters that are similar to older adults themselves). The patient perspective on doctor-patient communication is underrepresented in most research. This study aims to incorporate the patient perspective in different ways: in addressing their needs and barriers during focus group discussions, in collecting their communication strategies and solutions to these barriers in the role play exercise, in involving them in developing the photo novel, and in studying their responses to the photo novel in the evaluation study the investigators describe in this research proposal.

Read the detailed description

In this study, the researchers evaluate an intervention aiming to increase participation and communication of older adults during primary care consultations with their General Practitioner (GP). The researchers are particularly interested in a Photo novel tool with this aim. Photo novels are picture stories, which have the advantage of using a familiar narrative format, thereby possibly increasing comprehension, personal involvement and motivation and self-efficacy to perform the relevant behaviors by offering role models (story characters that are similar to older adults themselves). The patient perspective on doctor-patient communication is underrepresented in most research. This study aims to incorporate the patient perspective in different ways: in addressing their needs and barriers during focus group discussions, in collecting their communication strategies and solutions to these barriers in the role play exercise, in involving them in developing the photo novel, and in studying their responses to the photo novel in the evaluation study the researchers describe in this research protocol.

Aim of the intervention (the Photo novel) is to:

  1. increase older adults' awareness of their needs and barriers in conversations with their GP;
  2. improve older adults' access to information by enabling them to ask different and more questions to their GP;
  3. increase older adults' problem solving abilities during conversations with their GP to ensure better self-management of health issues.
  4. find out which format is most efficacious

This could include being honest about limited understanding, asking for more information to enable or improve shared decision making during consultation or to enable or improve self-management after consultation. This could also include filtering information and enabling patients to determine relevance of information. Furthermore, this could include strategies to translate advice into concrete actions, e.g. transforming 'knowing that' into 'knowing how' (I know / understand that I have to use less salt but… How to… decrease salt-intake in daily life?) In our photo novel, the researchers will provide older adults with 'template communicative behaviors' embedded in a picture story they can use before and during primary care consultations with their GP. Relevant communicative behaviors will include 'asking questions', 'expressing lack of or misunderstanding', 'expressing uncertainty', 'expressing preferences and needs' and other relevant communicative behaviors that will be identified during the focus group discussions with older adults and their informal care givers. These relevant communicative behaviors are embedded within different relevant domains, based on communication theory / literature and on the output of the focus group discussions. The seven scenarios are linked to the endpoints of medical communication framework developed by Haes and Bensing.

The researchers propose to evaluate the effectiveness of the photo novel using an Experimental Design, including both quantitative and qualitative measurements. This combination of measurements will provide us with insight with regard to three important Research Questions:

  1. To what extent is a photo novel an effective tool / intervention to empower older adults in their conversations with their GP compared to a traditional brochure containing tips on GP-patient communication?
  2. Which elements or domains included in the photo novel are effective and why?
  3. Which narrative / theoretical mechanisms account for the effectiveness of the photo novel ?

The researchers will recruit older adult participants (>50 years), who live in areas indicative of limited or marginal health literacy. The researchers perform the following procedure for recruitment. The researchers recommend to build relationships with GP practices, healthcare organizations and community organizations and ask them for their cooperation during a pre-established period of time. The researchers pay careful attention to this part of our study, e.g. carefully design recruitment wording: 'We are conducting a study to improve the relationship/ conversations with your GP, as a way to make sure the health care you receive is improved. We invite you to participate in this study. Would you like to participate?' Participants will be asked to come to a neutral setting, for example within the University, or will be visited in a community building, to take part in our study. Based on their consent to participate, a schedule is developed with eligible patients. Participants will be randomized to one of the two conditions and will be presented with the photo novel or traditional brochure either presented as a hard copy brochure or as pdf on a tablet computer (2x2 factorial design) and the accompanying questionnaire. The researchers aim for participants of different ages.

Being tested
Fotonovela
Keywords
Health Literacy, Health Ageing, Health Literacy Interventions, IROHLA, Photo Novel Study
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FotonovelaBehavioural

    Comparing fotonovela brochure to traditional brochure, as a template communicative behaviors embedded in a picture story where the older people could use before and during primary care consultations with their GP. Relevant communicative behaviors will include 'asking questions', 'expressing lack of or misunderstanding', 'expressing uncertainty', 'expressing preferences and needs' and other relevant communicative behaviors which are based on communication theory / literature and on the output of the focus group discussions.

    The researchers will randomly assigned the participants into four groups as described earlier. Mainly to identify the outcomes of the comparison between fotonovela and traditional brochure in both traditional hard-copy and in tablet.

Study groups in NCT02502292
Study groupRoleWhat they receive
Intervention: FotonovelaExperimentalThe Photo Novel Intervention is presented to users of four different facilities (sports clubs, senior homes) who are older than 50 years. The researchers welcome scheduled eligible participants, introduce the study and ask them for their consent. Afterwards, the participants are asked to fill in the questionnaire. Then, participants are randomized to one of the four groups and are presented with the photo novel or traditional brochure either as a hard copy brochure or as pdf on a tablet computer (2x2 group design). They are instructed to read the material in their own pace and answer the accompanying questions after each story / tip.and the accompanying questionnaire.
Receives: Behavioral: Fotonovela

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health literacy will be assessed by questions in a questionnaire

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502292
Sponsor's protocol ID
FP7/2007-2013
Acronym
IROHLA
Status last verified
Apr 2017
First submitted
6 Jul 2015
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Tan SL, Whittal A, Lippke S. Testing a Photo Story Intervention in Paper Versus Electronic Tablet Format Compared to a Traditional Brochure Among Older Adults in Germany: Randomized Controlled Trial. JMIR Aging. 2018 Dec 6;1(2):e12145. doi: 10.2196/12145.

    PubMed 31518254

Questions about this trial

What is this clinical trial studying?

A study testing Fotonovela in people with Health Behavior and Attitude to Health, run by Jacobs University Bremen gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health literacy will be assessed by questions in a questionnaire (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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