Clinical trial NCT03283358: Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Official title: Person-centered Follow up and Health Promotion Program After Revascularization for Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Keywords: Prevention and control
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow up and health promotion) program in comparison to standard follow up for patients treated with surgical or endovascular revascularization of Intermittent Claudication.

Detailed description: Specific Aims:

1. To evaluate the effect of the intervention program on patient's adherence to medication (anticoagulant agents, antiplatelet agents and lipid-lowering agents), risk modification and surgical treatment outcomes
2. To investigate the effect of the intervention program on patient reported outcomes
3. To investigate the effect of the intervention program on patient reported experiences
4. To investigate the long-term effect of the intervention program on mortality, cause of death, occurrence/recurrence of cardiovascular disease up to 10 years after the surgical/endovascular treatment
5. To compare patient-reported adherence to medication and patient data registry adherence to medication

Hypothesis: Participants in the Intervention Group have better adherence to prescribed medication and a reduced risk for 10-year predicted coronary heart disease (CHD) compared to participants in the Control Group.

Study population:

Patients with Intermittent Claudication scheduled for revascularization, through open surgery or endovascular method, in Stockholm will be screened for inclusion. After informed consent, the participants will be randomized to either Intervention Group or Control Group. Those participants who couldn't receive revascularization after giving consent will be withdrawn from the study and counted as drop outs. Power analysis has showed a required sample size of 186 participants to detect a statistically significant increase in adherence to medication from 50% to 70% (power 0.80, significance value 0.05, two-sided). Expecting 10% drop-out we plan to recruit 210 participants.

Data collection:

Data on primary and secondary outcomes, serum cholesterol, smoking status, serum carbon monoxide, Hba1c, BMI, waist circumference, physical exercise, diet, alcohol consumption, graft patency, re-intervention, hospitalization during the study year, mortality and patient characteristics/demographics will be collected at baseline and one year after treatment. All data will be registered at a local research data base at Karolinska Institutet. All patient-reported outcomes will be collected using web-based questionnaires linked to the data base.

Data analysis:

Comparisons between the Intervention Group and the Control Group will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data, and Fischers Exact test for categorical data. Logistic regression analysis will also be performed to adjust for confounding factors. All analyses will be performed according to the Intention-to-treat principle.

Eligibility criteria: Inclusion Criteria:

* Adult patients who is scheduled for revascularization, through open and/or endovascular surgery for IC diagnosed according to Diagnosis Related Group (DRG) with I70.2 or I739B

Exclusion Criteria:

* Patients not treated through surgery or revascularization
* Patients diagnosed with dementia
* Patients discharge to a nursery home,
* Patients not accountable for administrating their own medications
* Patients with a survival expectancy less than one year

Primary outcomes:
measure: Adherence to medication
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
Secondary outcomes:
measure: Risk for 10-year predicted coronary heart disease (CHD)
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
Other outcomes:
measure: Patient reported adherence to medication
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Generic Health-related Quality of Life (HRQOL)
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Condition specific Health-related Quality of Life (HRQOL)
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Beliefs on medication
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Self-efficacy
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Health literacy
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Patient-experienced quality of care
timeFrame: One year after surgical or endovascular treatment for Intermittent Claudication
measure: Mortality
timeFrame: Ten years after surgical or endovascular treatment for Intermittent Claudication
measure: Cardiovascular disease
timeFrame: Ten years after surgical or endovascular treatment for Intermittent Claudication
Locations:
city: Stockholm
country: Sweden
facility: Department of Surgery, Unit of Vascular Surgery, Södersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dept of Vascular Surgery
Study officials:
affiliation: Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
name: Anneli Linné, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haile S, Linne A, Johansson UB, Joelsson-Alm E. Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial. BMC Nurs. 2020 Jun 4;19:45. doi: 10.1186/s12912-020-00437-7. eCollection 2020.