Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: Name of intervention: Motivational interviewing Who will deliver the intervention and what is their training: The intervention will be delivered by an allied health professional who has received training in motivational interviewing, through workshop attendance, on‐line training, and one‐on‐one coaching from an expert motivational interviewing practitioner. Mode of delivery: Telephone Dose: There will be one session weekly for the first 8 weeks followed by two booster sessions, one at week‐12 and one at week‐16. The duration of each session will be 30 minutes. Location/Timing: The intervention will be delivered when participants have been discharged home from hospital to enable the motivational interviewing discussions to be contextualised to daily life. Procedures and Personalisation: The content of each session with each individual will follow the recommended process of Engagement, Focusing, Evoking and Planning. Sessions 1‐2 will focus on introduction and participant engagement while sessions 3‐8 will focus on increasing confidence about walking. As a means of sustaining outcomes participants will also receive 2 booster sessions focusing on maintenance of confidence in walking behaviour in weeks 12 and 16. Fidelity: The allied health professional’s proficiency and fidelity in using motivational interviewing (intervention fidelity) will be confirmed through audio‐recording of a small number of motivational interviewing sessions by an independent accredited assessor using the validated Motivational Interviewing Integrity scale. CONDITION: hip fracture; ; hip fracture Injuries and Accidents ‐ Fractures Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation PRIMARY OUTCOME: Daily time spent walking as assessed by accelerometer‐based activity monitor (activPAL)[Baseline, 9 weeks, 26 weeks and 52 weeks (primary endpoint) after randomisation] SECONDARY OUTCOME: Any injuries as a result of a fall as assessed by a brief survey of any participant reporting a fall in their falls calendar (see secondary outcome above)[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Confidence related to walking in different situations as assessed by the 22‐item Ambulatory Self‐Confidence Questionnaire[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Cost effectiveness from a health care system perspective, with outcomes based on the primary intermediate clinical outcome (daily time spent walking) and the secondary outcome of health‐related quality of life (AQoL‐8D) as assessed by incremental cost effectiveness ratios (ICER)[52 weeks after randomisation] Daily steps as assessed by an accelerometer‐based activity monitor (activPAL)[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Daily time sitting or lying as assessed by an accelerometer‐based activity monitor (activPAL)[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Daily time spent in moderate to vigorous activity as assessed by an accelerometer‐based activity monitor (activPAL) using a threshold of 60 steps/minute[Baseline, 9 weeks, 26 weeks, and 52 weeks after randomisation] Depression, anxiety, and stress as assessed by the 21‐item Depression Anxiety and Stress Scale[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Experiences of the allied health professionals who delivered the motivational interviewing intervention on the feasibility, advantages and disadvantages of the intervention as assessed by inductive thematic analysis of in‐depth semi‐structured interviews[26 weeks after randomisation] Exploration of perceptions about receiving the motivational interviewing intervention with participants in the motivational interviewing group as assessed by inductive thematic analysis of in‐depth semi‐structured interviews[26 weeks after randomisation] Exploration of experiences of rehabilitation after hip fracture, and recovery of mobility for a purposive sample of participants in both groups as assessed by inductive thematic analysis of in‐depth semi‐structured interviews[52 weeks after randomisation] Falls, as assessed by participants maintaining a falls calendar (participants will receive a monthly phone call reminder to return their falls calendar)[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Health‐related quality of life as assessed by the 35‐item Assessment of Quality of Life Instrument (AQoL) 8‐D [Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Healthcare utilisation and cost data will be collected via a patient health service utilisation questionnaire developed for the trial and will include questions on hospital admissions and community allied health visits not related to falls.[Baseline, 26 weeks and 52 weeks after randomisation] Hospital readmissions as assessed through participating health service databases.[9 weeks, 26 weeks and 52 weeks after randomisation] Medical services and pharmaceutical use as assessed by Medicare Australia records[52 weeks after randomisation] Mobility‐related function as assessed by the de Morton Mobility Index (DEMMI), a 15‐item unidimensional measure of mobility based on clinician observation[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Nutritional status as assessed by the Malnutrition Screening Tool, and body weight as assessed by digital scales[Baseline, 26 weeks and 52 weeks after randomisation] Participant‐report of whether they walk outdoors alone or with company, and to report the frequency of outdoor walks as assessed by a participation questionnaire reported by Ziden et al[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Self‐efficacy associated with walking and falls will be assessed with the 14‐item Modified Falls Efficacy Scale[Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] The frequency of domestic, outdoor, and leisure/work activities as assessed by the 15‐item Frenchay Activities Index [Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] Well being and capability as assessed by the 5‐item ICECAP‐O [Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation] INCLUSION CRITERIA: Participants will be included if they: • had a hip fracture (S72.0–S72.2 according to the International Classification of Diseases 10th revision (ICD‐10)), • live at home independently, • are aged 65 years or older, • have been discharged from hospital within the last 6 months, • are able to walk independently with or without an assistive device • can communicate with conversational English, • and are insufficiently active (defined as obtaining less than 150 minutes of moderate intensity activity per week). The level of baseline physical activity will be screened using an accelerometer‐based activity monitor over 7 days
Epistemonikos ID: d327c23512342a8fba3a730da2b39d72863bec93
First added on: Aug 24, 2024