Type2 DiabetesS4CNCT04266054
Stories for Change: Digital Storytelling for Diabetes Self-Management Among Somali Adults
A study testing Digital Storytelling Intervention in people with Type2 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
Somali adults are more likely to have type 2 diabetes mellitus (T2D) and more likely to die from the disease than non-Somali 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-Somali… 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 30 Jun 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as Somali
- Between 18 and 70 years of age.
- Receives primary care at Mayo Clinic ECH.
- 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%.
Who cannot join
- 1. Not eligible if someone in the same household is participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Somali adults are more likely to have type 2 diabetes mellitus (T2D) and more likely to die from the disease than non-Somali 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-Somali 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 Somali 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 Somali 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 format. The respective digital storytelling videos will be pilot tested with 80 patients in Rochester, MN. In a mirror project for Hispanic adults, 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 Somali adults.
Read the detailed description
The study team will conduct a two-group randomized controlled trial in a primary care clinical setting at Mayo Clinic in Rochester, MN with Somali 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. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.
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 Somali populations compared with non-Somali 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: 6 months
Secondary outcomes (5)
Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).
This is a brief survey instrument to assess the following domains: general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose monitoring. In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA was one of only three instruments to meet all appraisal criteria113. The SDSCA is also the most commonly used instrument for these domains worldwide, with good validity evidence in several languages. The SDSCA will be administered by the same language-congruent study staff at each measure.
Measured: 6 months
Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an automated blood pressure device after sitting quietly for five minutes.
Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.
Measured: 6 months
Body mass index
Weight will be measured to the nearest 0.1 kg using a clinical scale. Height will be measured in cm with a stadiometer. BMI is calculated as weight (kg)/height squared (m2).
Measured: 6 months
Total cholesterol, HDL cholesterol, will be measured from the same blood sample used to derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values.
Baseline LDL-cholesterol values will be drawn at the baseline study visit. Cholesterol values at 3 months will be drawn at the 3 month study visit. Subsequent cholesterol levels will not be drawn or abstracted.
Measured: 3 months
triglycerides will be measured from the same blood sample used to derive the outcome measure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start3 Dec 2019
- Primary completion8 May 2022
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane W. Njeru, M.B., Ch.B., Mayo Clinic
- Investigators
- Jane Njeru, MB, ChB, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266054
- Sponsor's protocol ID
- 19-008588
- Acronym
- S4C
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2020
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 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 Somali Adults
- ClinicalTrials.gov ID
- NCT04266054
- Acronym / sponsor ID
- S4C / 19-008588
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Feb 2020 (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.
Somali adults are more likely to have type 2 diabetes mellitus (T2D) and more likely to die from the disease than non-Somali 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-Somali 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 Somali 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 Somali 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 format. The respective digital storytelling videos will be pilot tested with 80 patients in Rochester, MN. In a mirror project for Hispanic adults, 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 Somali adults.
Detailed description
The study team will conduct a two-group randomized controlled trial in a primary care clinical setting at Mayo Clinic in Rochester, MN with Somali 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
Key inclusion criteria (8 listed)
- Self-identifies as Somali
- Between 18 and 70 years of age.
- Receives primary care at Mayo Clinic ECH.
- 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.
Key exclusion criteria (1 listed)
- 1. Not eligible if someone in the same household is participating in the study.
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. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.
Time frame: 6 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 Somali populations compared with non-Somali 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.
5 secondary outcomes
Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).
Time frame: 6 months
Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an automated blood pressure device after sitting quietly for five minutes.
Time frame: 6 months
Body mass index
Time frame: 6 months
Total cholesterol, HDL cholesterol, will be measured from the same blood sample used to derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values.
Time frame: 3 months
triglycerides will be measured from the same blood sample used to derive the outcome measure.
Time frame: 3 months
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 5 Jul 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Jane Njeru, MB, ChB principal investigator
Mayo Clinic
1 site 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 1 site 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?
The sponsor lists 8 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 5 Jul 2024. 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 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?
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?
Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024.