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Diabetes Mellitus, Type 2NCT04616053

IMPACT Intervention

A study testing IMPACT intervention in people with Diabetes Mellitus, Type 2, run by Pole de Sante Chambery Nord.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction : The prevalence of type 2 diabetes is increasing in France, especially in deprived districts. The Itineraires Medico-sociaux Programme d'Accompagnement sur un Territoire (IMPACT) intervention is intended for disadvantaged patients with a chronic disease (not only type 2 diabetes). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
IMPACT intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
Sep 2021to Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes
  • Live in Hauts de Chambéry, Biollay or Renaudie district
  • Be able to give written consent

Who cannot join

  • Severe cognitive or psychological disorder that may affect study understanding
  • Pregnant or breastfeeding women
  • Had IMPACT intervention in the previous 24 months
  • Concurrent participation in another study
  • Concurrent participation in another diabetes educational care program
  • Life expectancy less than 6 months

Trial locations and contacts

No sites are listed yet.

Donatien Talon, Resident contact

+33679230064

donatien.talon@gmail.com

About this study

Official title: A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.

Introduction :

The prevalence of type 2 diabetes is increasing in France, especially in deprived districts.

Read more

The Itineraires Medico-sociaux Programme d'Accompagnement sur un Territoire (IMPACT) intervention is intended for disadvantaged patients with a chronic disease (not only type 2 diabetes).

The IMPACT intervention offers coordinated and patient-centered care by a multidisciplinary team with an empowerment approach. This personalised intervention lasts 6 months.

This study aims to evaluate the effect of 6 months IMPACT intervention on glycaemic control (glycated haemoglobin - HbA1c) of patients with type 2 diabetes in deprived districts.

Method :

This will be a randomised, controlled, parallel group, multicenter, open-label trial. 140 adults with type 2 diabetes will be randomised in two arms : IMPACT intervention group (n : 70) and usual care group (n : 70). The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model.

Read the detailed description

This will be a randomised, controlled, parallel group, multicenter, open-label trial. Patients will be recruited among patients with type 2 diabetes referred to the IMPACT intervention.

144 patients will be randomised in two arms : IMPACT intervention group (n : 72) and usual care group (n : 72).

IMPACT intervention : a referent is assigned to the patient. A referent is a health worker (nurse, nutritionist, psychologist …). Patient builds with his referent a free care program. The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …). A community health worker can help patients with his health administrative procedures.

Patients will have 3 visits. First visit (inclusion visit) : investigator collects baseline characteristics (sociodemographic data, comorbidity, treatment, diabetes complications, weight, height, body mass index, impedancemetry, HbA1c, lipids, creatinine, albuminuria/creatinuria ratio). Then the patient will be randomised.

Second visit (midpoint visit) : investigator collects weight, BMI, impedancemetry, HbA1c and adverse events Third visit (end point visit) : investigator collects weight, BMI, impedancemetry, HbA1c, lipids and adverse events.

Analysis : The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model. Study groups, districts, time, group-time interaction and district-group interaction will be included as fixed effects. The model will include patients as a random effect. Sub-group analysis will be made with baseline HbA1c, sex, age, Epices score (French precarity score) and diabetes duration. The robustness of the model will be tested by replacing missing data with multiple imputation methods. The same statistical modelling approach will be used for the secondary outcomes.

Being tested
IMPACT intervention
Keywords
primary health care, patient-centered care, poverty areas, vulnerable populations, Glycated Hemoglobin A
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • IMPACT interventionBehavioural

    A referent is assigned to the patient. A referent is a health worker (nurse, nutritionist, psychologist …). Patient builds with his referent a free care program (without condition or limit). The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …). A community health worker can help patient with his health administrative procedures. This intervention lasts 6 months.

Study groups in NCT04616053
Study groupRoleWhat they receive
Intervention groupExperimentalIMPACT intervention
Receives: Behavioral: IMPACT intervention
Control groupNo interventionUsual care

What is being measured

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

  1. HbA1c

    Change in glycated haemoglobin (HbA1c)

    Measured: From baseline to 6 months

Secondary outcomes (9)

  1. HbA1c

    Change in glycated haemoglobin (HbA1c)

    Measured: From baseline to 3 months

  2. Weight

    Change in weight

    Measured: At Months 3 and 6 from baseline

  3. Body mass index

    Change in body mass index

    Measured: At Months 3 and 6 from baseline

  4. Body fat mass (Bioelectrical impedance analysis)

    Change in body fat mass

    Measured: At Months 3 and 6 from baseline

  5. Body fat percentage (Bioelectrical impedance analysis)

    Change in body fat percentage

    Measured: At Months 3 and 6 from baseline

  6. Muscle mass (Bioelectrical impedance analysis)

    Change in muscle mass.

    Measured: At Months 3 and 6 from baseline

  7. Lipids - HDL cholesterol

    Change in HDL cholesterol

    Measured: From baseline to 6 months

  8. Lipids - LDL cholesterol

    Change in LDL cholesterol

    Measured: From baseline to 6 months

  9. Lipids - triglycerides

    Change in triglycerides

    Measured: From baseline to 6 months

Timeline

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

  1. First posted4 Nov 2020
  2. Study startSep 2021 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionMar 2024 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616053
Sponsor's protocol ID
2020-A02905-34
Status last verified
Nov 2020
First submitted
27 Oct 2020
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.

    PubMed 22683130

  • Attridge M, Creamer J, Ramsden M, Cannings-John R, Hawthorne K. Culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2014 Sep 4;2014(9):CD006424. doi: 10.1002/14651858.CD006424.pub3.

    PubMed 25188210

  • Captieux M, Pearce G, Parke HL, Epiphaniou E, Wild S, Taylor SJC, Pinnock H. Supported self-management for people with type 2 diabetes: a meta-review of quantitative systematic reviews. BMJ Open. 2018 Dec 14;8(12):e024262. doi: 10.1136/bmjopen-2018-024262.

    PubMed 30552277

Questions about this trial

What is this clinical trial studying?

A study testing IMPACT intervention in people with Diabetes Mellitus, Type 2, run by Pole de Sante Chambery Nord.

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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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?

Results are not available in the source record.

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

Contact Donatien Talon, Resident (+33679230064, donatien.talon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: From baseline to 6 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 NCT04616053, which also lists 3 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 4 Nov 2020.

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