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Feasibility of a Multi Site RCT to Establish the Effectiveness of a Health Behaviour Change Intervention for Patients With Peripheral Arterial Disease (PAD).

NCT04753281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-02-15

No results posted yet for this study

Summary

The purpose of this study was to evaluate the feasibility of conducting a randomised controlled trial (RCT) comparing brief psychological intervention to help patients with Peripheral Arterial Disease (PAD), reduce cardiovascular risk factors compared to control/treatment as usual in a vascular outpatient clinic. Trial feasibility was defined as the successful recruitment and retention of participants, adherence to the intervention, identification of barriers to the intervention and collection of clinical and quality of life outcome data. Qualitative data was collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting.

Conditions

  • Health Behavior

Interventions

OTHER

Lifestyle counselling

brief psychological intervention, based on the behaviour change whee

Sponsors & Collaborators

  • NHS Grampian

    lead OTHER_GOV

Principal Investigators

  • Mary Mccallum · NHSGRAMPIAM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2019-11-05
Completion
2019-11-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753281 on ClinicalTrials.gov