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.
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
- Conditions the study is for
- Health Behavior, Attitude to Health, Impaired Health
- What is being tested?
- Fotonovela
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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:
- increase older adults' awareness of their needs and barriers in conversations with their GP;
- improve older adults' access to information by enabling them to ask different and more questions to their GP;
- increase older adults' problem solving abilities during conversations with their GP to ensure better self-management of health issues.
- 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:
- 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?
- Which elements or domains included in the photo novel are effective and why?
- 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.
- Conditions
- Health Behavior, Attitude to Health, Impaired Health
- 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 group | Role | What they receive |
|---|---|---|
| Intervention: Fotonovela | Experimental | The 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.
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.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
- Investigators
- Sonia Lippke, Prof.Dr., Principal investigator, Jacobs University BremenRuth Koops van 't Jagt, Msc., Principal investigator, Reichuniversität Groningen/UMCG
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Health Systems Through Health Literacy for Healthy Aging
- ClinicalTrials.gov ID
- NCT02502292
- Acronym / sponsor ID
- IROHLA / FP7/2007-2013
- Conditions
- Health Behavior, Attitude to Health, Impaired Health
- Keywords
- Health Literacy, Health Ageing, Health Literacy Interventions, IROHLA, Photo Novel Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- increase older adults' awareness of their needs and barriers in conversations with their GP;
- improve older adults' access to information by enabling them to ask different and more questions to their GP;
- increase older adults' problem solving abilities during conversations with their GP to ensure better self-management of health issues.
- 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:
- 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?
- Which elements or domains included in the photo novel are effective and why?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Fotonovela | Experimental | Behavioral: FotonovelaThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Areas indicative of limited or marginal health literacy
- Carry out in a neutral setting
Key exclusion criteria (1 listed)
- Eye-sight or hearing disabled people. This is because this study requires participants have the ability to read and watch and listen to videos.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FotonovelaComparing 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. | Behavioural | Intervention: Fotonovela |
Primary outcome
Health literacy will be assessed by questions in a questionnaire
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 31518254Tan 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.
- Homepage of the official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Lippke, Prof.Dr. principal investigator
Jacobs University Bremen
Ruth Koops van 't Jagt, Msc. principal investigator
Reichuniversität Groningen/UMCG
1 site in 1 country: see every site and its status.
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.