Type2 DiabetesS4CNCT03766438
Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
A study testing Digital Storytelling Intervention in people with Type2 Diabetes, run by Mayo Clinic at 3 sites in United States.
Trial summary
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Digital Storytelling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2019to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Self-identifies as Hispanic or Latino.
- Between 18 and 70 years of age.
- Receives primary care at the clinical site.
- Visited the primary care site at least once in the least twelve months.
- Intention to continue receiving care at the clinic for the next six months.
- Diagnosis of T2D in medical record.
- T2D diagnosis for six months or longer.
- Most recent hemoglobin A1c≥8%.
Not eligible if someone in the same household is participating in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hennepin Healthcare
Minneapolis, Minnesota, 55404
Mountain Park Health Center
Phoenix, Arizona, 85012
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities.
Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP)
Read more
Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs.
RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change.
The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults.
Read the detailed description
The study team will conduct a two-group randomized controlled trial in primary care clinical settings at two healthcare institutions among 450 Hispanic adults with poorly controlled T2D (hemoglobin A1c≥8%). The intervention group will view the 12-minute digital storytelling video. Both the intervention and comparison groups will receive diabetes education and resource cards, as well as usual clinical care. The primary outcome will be glycemic control as measured by hemoglobin A1c 3 months after intervention delivery. Secondary outcomes will include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and body mass index. The impact of concomitant covariates, including sex, age, and socio-economic status, on the sensitivity of the intervention effect will also be explored.
- Conditions
- Type2 Diabetes
- Being tested
- Digital Storytelling Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Storytelling InterventionBehavioural
12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Receives: Behavioral: Digital Storytelling Intervention |
| Control | No intervention | The comparison group will receive usual clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months
The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes.
Measured: Baseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start14 Feb 2019
- Primary completion1 Nov 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin Healthcare, Mountain Park Health Center - Phoenix, AZ, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Mark L Wieland, Mayo Clinic
- Investigators
- Mark L Wieland, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766438
- Sponsor's protocol ID
- 18-002998
- Other IDs
- R01DK113999-01A1
- Acronym
- S4C
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wieland ML, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Iteghete S, Patten CA, Njeru JW, Lohr AM, O'Byrne J, Novotny PJ, Singh DP, Larkey LK, Goodson M, Capetillo GP, Sia IG. Digital Storytelling Intervention for Hemoglobin A1c Control Among Hispanic Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2424781. doi: 10.1001/jamanetworkopen.2024.24781.
PubMed 39093566Lohr AM, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Patten CA, Njeru JW, Novotny PJ, Larkey LK, Singh D, Wieland ML, Sia IG. Stories for change protocol: A randomized controlled trial of a digital storytelling intervention for Hispanic/Latino individuals with type 2 diabetes. Contemp Clin Trials. 2023 Mar;126:107093. doi: 10.1016/j.cct.2023.107093. Epub 2023 Jan 20.
PubMed 36682492
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
- ClinicalTrials.gov ID
- NCT03766438
- Acronym / sponsor ID
- S4C / 18-002998
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Hennepin Healthcare, Mountain Park Health Center - Phoenix, AZ, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities.
Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP)
Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs.
RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change.
The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults.
Detailed description
The study team will conduct a two-group randomized controlled trial in primary care clinical settings at two healthcare institutions among 450 Hispanic adults with poorly controlled T2D (hemoglobin A1c≥8%). The intervention group will view the 12-minute digital storytelling video. Both the intervention and comparison groups will receive diabetes education and resource cards, as well as usual clinical care. The primary outcome will be glycemic control as measured by hemoglobin A1c 3 months after intervention delivery. Secondary outcomes will include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and body mass index. The impact of concomitant covariates, including sex, age, and socio-economic status, on the sensitivity of the intervention effect will also be explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digital Storytelling InterventionThe intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. |
| Control | No intervention | –The comparison group will receive usual clinical care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Digital Storytelling Intervention12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories. | Behavioural | Intervention |
Primary outcome
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months
Time frame: Baseline and 3 months.
The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39093566Wieland ML, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Iteghete S, Patten CA, Njeru JW, Lohr AM, O'Byrne J, Novotny PJ, Singh DP, Larkey LK, Goodson M, Capetillo GP, Sia IG. Digital Storytelling Intervention for Hemoglobin A1c Control Among Hispanic Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2424781. doi: 10.1001/jamanetworkopen.2024.24781.
- Derived from this study: PubMed 36682492Lohr AM, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Patten CA, Njeru JW, Novotny PJ, Larkey LK, Singh D, Wieland ML, Sia IG. Stories for change protocol: A randomized controlled trial of a digital storytelling intervention for Hispanic/Latino individuals with type 2 diabetes. Contemp Clin Trials. 2023 Mar;126:107093. doi: 10.1016/j.cct.2023.107093. Epub 2023 Jan 20.
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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.
Mark L Wieland principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Storytelling Intervention in people with Type2 Diabetes, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months (time frame: Baseline and 3 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 NCT03766438, which also lists 2 linked publications.
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 8 Oct 2024.