Health LiteracyNCT07878403
The Health Literacy for Healthier Mind Study
A study testing The Health Literacy for Healthier Mind study in people with Health Literacy and Occupational Health, run by Molde University College.
Trial summary
Health literacy is critical for patient safety, quality of care, and long-term health outcomes, yet health professionals often lack the support, time, and tools to deliver health literacy-sensitive care (health literacy sensitivity is the knowledge, skills, and attitudes health professionals require to effectively… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Literacy, Occupational Health, Mental Health
- What is being tested?
- The Health Literacy for Healthier Mind study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Interdisciplinary healthcare personnel working in the intervention ward. treating patients with heart, lung, and geriatric conditions.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Health Literacy-Sensitive Care and Health Professionals' Well-Being - A Multicenter Quasi-Experimental Controlled Study
Health literacy is critical for patient safety, quality of care, and long-term health outcomes, yet health professionals often lack the support, time, and tools to deliver health literacy-sensitive care (health literacy sensitivity is the knowledge, skills, and attitudes health professionals require to effectively meet patients' health literacy needs). Building on a successful feasibility study showing that a targeted intervention can enhance health literacy sensitivity and teamwork without harming mental or occupational well-being. The Health Literacy for Healthier Minds study will build on these positive results and test a scalable, multi-component intervention in four Norwegian hospitals. The study aims to strengthen health professionals' health literacy sensitivity, safeguard their mental and occupational well-being, and explore patients' experiences with health literacy-sensitive care.
- Being tested
- The Health Literacy for Healthier Mind study
- Keywords
- Health literacy, Occupational well-being, Mental well-being, Hospital, Healthcare personnel
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Health Literacy for Healthier Mind studyBehavioural
The Health Literacy for Healthier Mind study will provide the intervention wards with routines and resources, including internal education, project and reflection groups, and a trained HL nurse. The HL nurse will be clinically present to support and guide colleagues in HL-sensitive care.
| Study group | Role | What they receive |
|---|---|---|
| One medical ward in West Norway 1.0 | Experimental | The intervention ward will receive resources and routines for HL-sensitive care. Receives: Behavioral: The Health Literacy for Healthier Mind study |
| One medical ward in West Norway 1.1 | No intervention | Controll post |
| One medical ward in East Norway 2.0 | Experimental | The intervention ward will receive resources and routines for HL-sensitive care. Receives: Behavioral: The Health Literacy for Healthier Mind study |
| One medical ward in East Norway 2.1 | No intervention | Controll post |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy sensitivity
The knowledge, skills, and attitudes that healthcare personnel have to meet patients' and families' HL needs.
We will use the Norwegian version of the validated tool, the Instrument of Health Literacy Competency (IOHLC), to measure the primary outcome. We will use all nine domains of the IOHLC.
Measured: Measures at baseline, after six months and at the end of the intervention periode, 12 months.
Secondary outcomes (3)
Work engagement
Work engagement will be measured using the Utrecht Work Engagement Scale (UWES-3).
Measured: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Work environment
Work environment will be measured using the Practice Environment Scale (PES-5),
Measured: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Emotional exhaustion
will be measured using the subscale of the Maslach Burnout Inventory; and symptoms of anxiety and depression will be measured using the Norwegian version Of Hopkins Symptom Checklist-5 (HSCL-5)
Measured: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
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 LiteracyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878403
- Sponsor's protocol ID
- 44041
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stavdal MN, Larsen MH, Sjetne IS, Wahl AK, Gay CL, Kjetland MB, Lerdal A, Raheim Borge C. A health literacy intervention for registered nurses: Development and feasibility testing. Int J Nurs Stud Adv. 2026 Feb 5;10:100503. doi: 10.1016/j.ijnsa.2026.100503. eCollection 2026 Jun.
PubMed 41704896
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Literacy-Sensitive Care and Health Professionals' Well-Being - A Multicenter Quasi-Experimental Controlled Study
- ClinicalTrials.gov ID
- NCT07878403
- Acronym / sponsor ID
- 44041
- Keywords
- Health literacy, Occupational well-being, Mental well-being, Hospital, Healthcare personnel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 16 Oct 2026 (actual)
- 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.
Health literacy is critical for patient safety, quality of care, and long-term health outcomes, yet health professionals often lack the support, time, and tools to deliver health literacy-sensitive care (health literacy sensitivity is the knowledge, skills, and attitudes health professionals require to effectively meet patients' health literacy needs). Building on a successful feasibility study showing that a targeted intervention can enhance health literacy sensitivity and teamwork without harming mental or occupational well-being. The Health Literacy for Healthier Minds study will build on these positive results and test a scalable, multi-component intervention in four Norwegian hospitals. The study aims to strengthen health professionals' health literacy sensitivity, safeguard their mental and occupational well-being, and explore patients' experiences with health literacy-sensitive care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One medical ward in West Norway 1.0 | Experimental | Behavioral: The Health Literacy for Healthier Mind studyThe intervention ward will receive resources and routines for HL-sensitive care. |
| One medical ward in West Norway 1.1 | No intervention | –Controll post |
| One medical ward in East Norway 2.0 | Experimental | Behavioral: The Health Literacy for Healthier Mind studyThe intervention ward will receive resources and routines for HL-sensitive care. |
| One medical ward in East Norway 2.1 | No intervention | –Controll post |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Interdisciplinary healthcare personnel working in the intervention ward. treating patients with heart, lung, and geriatric conditions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The Health Literacy for Healthier Mind studyThe Health Literacy for Healthier Mind study will provide the intervention wards with routines and resources, including internal education, project and reflection groups, and a trained HL nurse. The HL nurse will be clinically present to support and guide colleagues in HL-sensitive care. | Behavioural | One medical ward in East Norway 2.0, One medical ward in West Norway 1.0 |
Primary outcome
Health literacy sensitivity
Time frame: Measures at baseline, after six months and at the end of the intervention periode, 12 months.
The knowledge, skills, and attitudes that healthcare personnel have to meet patients' and families' HL needs. We will use the Norwegian version of the validated tool, the Instrument of Health Literacy Competency (IOHLC), to measure the primary outcome. We will use all nine domains of the IOHLC.
3 secondary outcomes
Work engagement
Time frame: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Work environment
Time frame: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Emotional exhaustion
Time frame: Baseline, 6-months after intervention start and at the end of the intervention periode, 12-months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 41704896Stavdal MN, Larsen MH, Sjetne IS, Wahl AK, Gay CL, Kjetland MB, Lerdal A, Raheim Borge C. A health literacy intervention for registered nurses: Development and feasibility testing. Int J Nurs Stud Adv. 2026 Feb 5;10:100503. doi: 10.1016/j.ijnsa.2026.100503. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The Health Literacy for Healthier Mind study in people with Health Literacy and Occupational Health, run by Molde University College.
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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malene N Stavdal, PhD (+47 40223099, malene.n.stavdal@himolde.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy sensitivity (time frame: Measures at baseline, after six months and at the end of the intervention periode, 12 months.). 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 NCT07878403, 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.