Trial Outcomes & Findings for Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness (NCT NCT00229957)

NCT ID: NCT00229957

Last Updated: 2010-07-20

Results Overview

health related quality of life. Minimum: 0; Maximum 100.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 303 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2010-07-20

Participant Flow

All participants recruited from a family health practice.

Participant milestones

Measure	Intervention Group A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.	Control Group Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
Overall Study STARTED	152	151
Overall Study COMPLETED	132	139
Overall Study NOT COMPLETED	20	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness

Baseline characteristics by cohort

Measure	Intervention Group n=152 Participants A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.	Control Group n=151 Participants Usual care from the primary health care team which did not include physiotherapy or occupational therapy.	Total n=303 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	86 Participants n=7 Participants	172 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	94 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 months

health related quality of life. Minimum: 0; Maximum 100.

Outcome measures

Measure	Intervention Group n=132 Participants A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.	Control Group n=139 Participants Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
SF-36 Physical Component	42.6 units on a scale Standard Deviation 11.8	43.1 units on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: baseline, 15 months

self report use of hospital service

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

self-reported number of falls in last 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 15 months

Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 months

Patient satisfaction with the care they received. (Score range 0-5)

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Richardson

McMaster University

Phone: 905-525-9140

Email: jrichard@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place