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Improving Adherence and Commitment to Treatment in Diabetic Patients

Impact:Improving Adherence and Commitment to Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02530840
Enrollment
500
Registered
2015-08-21
Start date
2014-07-31
Completion date
2018-03-31
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

imbalanced diabetic patients, HbA1c, peers

Brief summary

In the IMPACT project, the investigators want to improve adherence and commitment to treatment.

Detailed description

In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.

Interventions

BEHAVIORALmedical team

Lowering HbA1c by behavioral changes in meetings with the medical team.

BEHAVIORALpeers group

Lowering HbA1c by behavioral changes in meetings with the peers group.

Lowering HbA1c by behavioral changes in meetings with the SMS notification

Sponsors

Clalit Health Services
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. type 2 diabetes 2. age 30-70 3. Oral medication or insulin 4. According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment 5. BMI\<35 6. Patients speak and read Hebrew 7. owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)

Exclusion criteria

1. Active malignant disease 2. creatinine levels above 2 3. Getting medicines that elevate sugar levels as steroids, chemotherapy 4. Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event 5. Patients who are planning major surgery 6. Patients who are planning a residential zone change 7. Patients with acute complications of diabetes under active treatment (such as limb amputation) 8. Patients diagnosed with unbalanced mental disorders 9. patients who can not sign the form on their own informed consent 10. patients suffering from dementia 11. Patients who are not mobile (dependent on the therapist)

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Control as Expressed by the Change in HbA1c %0, 6, 12 & 18 monthsParticipants will undergo HbA1c periodical lab test, the data needed for the trial will be extracted from electronic medical record

Countries

Israel

Contacts

Primary ContactMargalit Goldfracht, prof.
MargalitGo@clalit.org.il+972-50-6263-214
Backup ContactNiky Liberman, DR
nickyli@clalit.org.il+972-50-6263050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026