Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers (DiaFOTo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Helse Stavanger HF
Sponsor:
Collaborators:
Helse Vest
The Norwegian Diabetes Association
Bergen University College
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01710774
First received: October 17, 2012
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.


Condition Intervention
Diabetic Foot
Foot Ulcer
Procedure: Telemedicine follow-up care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • healing time for diabetes related foot ulcer [ Time Frame: one year ] [ Designated as safety issue: No ]
    Healing time for diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months).


Secondary Outcome Measures:
  • Total number of consultations per person at the Section of Endocrinology [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of consultations from baseline until the foot ulcer has healed

  • sequela directly related to the foot ulcer [ Time Frame: one year ] [ Designated as safety issue: No ]
    From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study

  • Diabetes-related stress [ Time Frame: one year ] [ Designated as safety issue: No ]
    Diabetes-related stress, measured by using the Problem Areas in Diabetes. Measured at baseline and when the ulcer has healed (or the end of the study)

  • Symptoms of anxiety and depression [ Time Frame: one year ] [ Designated as safety issue: No ]
    symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.

  • Nordic Patient Experiences Questionnaire [ Time Frame: one year ] [ Designated as safety issue: No ]
    Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.

  • EQ-5D [ Time Frame: one year ] [ Designated as safety issue: No ]
    Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.

  • Sick leave [ Time Frame: one year ] [ Designated as safety issue: No ]
    Sick leave (number of days with a medical certificate) measured by obtaining data from the Norwegian Sick Leave Registry measured from baseline unntil the ulcer is healed (or at the end of the study)

  • A new foot ulcer appears, the incidence of amputation and survival. [ Time Frame: 2 and 3 years after the end of the study ] [ Designated as safety issue: No ]
    The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.


Estimated Enrollment: 276
Study Start Date: October 2012
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Traditional follow-up
Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up.
Active Comparator: Telemedicine follow-up care
Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
Procedure: Telemedicine follow-up care
Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care

Detailed Description:

The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily increasing proportion of older people in the population, will present enormous challenges for health care services in Norway. An epidemiologic study of diabetes-related foot ulcers among community-dwelling adults, including older people, based on data from the Nord-Trøndelag Health Study (HUNT2) showed that a history of foot ulcer was significantly associated with increased mortality and that about 10% of the people with diabetes reported a history of foot ulcer. Studies have shown that a foot ulcer is associated with reduced quality of life, social limitations and pain. Treating foot ulcers costs society considerable money. These results emphasize that diabetes-related foot ulcers represent a challenge for the individual and for health care services. Health care services need to rapidly begin treatment for people with diabetes-related foot ulcers to ensure high-quality treatment.

Telemedicine innovations for health care services have developed considerably in recent decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of information and communication technologies is an important way of achieving health policy aims in establishing more integrated diagnosis, treatment and care pathways across organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown that using telemedicine equipment enables follow-up care of similar quality to traditional consultations while enabling more flexible organization and greater patient satisfaction. A few minor quantitative studies show positive gains when telemedicine equipment is used in following up diabetes-related foot ulcers, but no randomized controlled studies have been performed in this field. Further, studies focusing on the more long-term effects are lacking.

The project is in accordance with national guidelines and will contribute to increasing the focus on research related to integrated care. We expect this project to provide evidence about alternative care pathways with a holistic approach that could moderate increases in the cost of health care services by delivering a larger proportion of services in municipal primary care. The project will be able to provide new evidence on meeting the challenges of diabetes-related care more systematically and proactively. We expect that the results of this study will contribute to showing the extent to which treatment at the lowest effective service level will be more cost-effective and of good or better quality than traditional clinical follow-up. This study can and will contribute to setting priorities for the users' needs for flexible health services and enabling more patients to be treated near their homes.

If the study finds evidence of positive health gains for the individual people with diabetes and contributes to high quality of care, this new model can be implemented in the entire Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist health care to be used more appropriately, and the team will be more accessible for health care personnel in municipal primary health care. This model can be transferred to other hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal primary health care.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first time within a period of 6 months to the Section of Endocrinology of Stavanger University Hospital.
  • The participants must be able to read and speak Norwegian.
  • The participants must be 20 years or older.

Exclusion Criteria:

  • people treated for an ulcer on the ipsilateral foot during the past 6 months in specialist health care
  • people with life expectancy of less than 1 year because of anticipated problems with follow-up
  • people with severe mental disorders or cognitive impairment, including schizophrenia, other psychotic disorders and dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710774

Locations
Norway
Stavanger HF Recruiting
Stavanger, Rogaland, Norway, 4068
Contact: Marjolein M. Iversen, PhD    +47 55 58 55 18    miv@hib.no   
Contact: Berit Rokne, PhD    +47 55 58 83 58    berit.rokne@rektor.uib.no   
Sponsors and Collaborators
Helse Stavanger HF
Helse Vest
The Norwegian Diabetes Association
Bergen University College
Investigators
Principal Investigator: Marjolein M. Iversen, PhD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01710774     History of Changes
Other Study ID Numbers: SUS-ID210
Study First Received: October 17, 2012
Last Updated: April 5, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Helse Stavanger HF:
Diabetic Foot
Diabetes Mellitus
Foot Ulcer
Wound Healing
Delivery of Health Care
Depression
sequela
Sick Leave
Quality of Life
Amputation

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Ulcer
Pathologic Processes
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 24, 2014