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

Diabetic Foot Clinical Trial

— DiaFOTo  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01710774
• Other study ID #: SUS-ID210
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2024

Study information

• Verified date: June 2021
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) 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.

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 and the individual with diabetes in Norway. Therefore, 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. The investigators 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. The investigators 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.

The main study confirmed that TM was non-inferior in traditional treatment with regard to healing time (primary outcome). The TM group had a significantly lower proportion of amputations, and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group.

There is a need to continue the study with additional patients to gain more knowledge about the extent to which the telemedicine follow-up affects the number of consultations (secondary outcome), inclusion of participants during 2019-2021. In addition, there is a need for more knowledge about the effect of telemedicine follow-up for patients with leg ulcers and in people without diabetes. The investigators have used qualitative interview as a process evaluation in this study and will investigate process variables more systematically in the further follow-up. By examining how the services are organized (organization and structure) the investigators will gain knowledge how the variation in the organization of telemedicine follow-up is affecting the outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 241
• Est. completion date: December 2024
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 and people without diabetes presenting a venous leg ulcer

• The participants must be able to read and speak Norwegian.

• The participants must be 20 years or older.

Exclusion Criteria:

• people treated for an diabetes foot ulcer on the ipsilateral foot during the past 6 months in specialist health care

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stord Hospital, Helse Fonna HF	Leirvik
Norway	Stavanger HF	Stavanger	Rogaland

Sponsors (6)

Lead Sponsor	Collaborator
Helse Stavanger HF	Bergen University College, Helse Vest, Norwegian Diabetes Association, Norwegian Nurses Organisation, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing time for leg ulcer and/or diabetes related foot ulcer	Healing time for leg ulcer and/or 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). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as <40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.	one year
Secondary	Total number of consultations per patient	Number of consultations from baseline until the foot ulcer has healed	one year
Secondary	sequela directly related to the foot ulcer	From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study	one year
Secondary	Diabetes-related stress	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)	one year
Secondary	Symptoms of anxiety and depression	symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.	one year
Secondary	Nordic Patient Experiences Questionnaire	Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.	one year
Secondary	EQ-5D	Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.	one year
Secondary	Sick leave	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)	one year
Secondary	A new foot ulcer appears, the incidence of amputation and survival.	The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.	2 and 3 years after the end of the study