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. 2019 Mar 14;2019(3):CD010748. doi: 10.1002/14651858.CD010748.pub2

Higgins 2001.

Methods Study design: parallel RCT
Recruitment: consecutive PCI patients; June 1995‐January 1997
Allocation: not reported
Blinding: not reported
Randomisation: no method described
Follow‐up(s): 10 weeks (range: 8‐26 weeks); 51 weeks (range: 36‐56 weeks)
Description: combined rehabilitation programme
Participants Baseline characteristics
Intervention group

  • Mean age (range): 48 (31‐63)

  • Sex (male %): 83

  • Number of participants randomised: 54

  • Working before CHD: 34


Control group

  • Mean age (range): 47 (26‐63)

  • Sex (male %): 96

  • Number of participants randomised: 51

  • Working before CHD: 23


Inclusion criteria

  • Employed within the previous year

  • No MI within 1 month before the PCI procedure


Exclusion criteria

  • Malignancy

  • History of cerebrovascular accident

  • "Severe, chronic debilitating disease"

  • Previous CABG

  • Peri‐PCI complications: MI, emergency CABG, persistent unstable angina during admission

  • "Participants who required surgical management at some time during the one‐year duration of study"


Baseline imbalances:

  • Sedentary lifestyle: intervention group: 35 (65%); control group: 27 (53%)

  • BMI > 35: intervention group: 43 (80%); control group: 32 (63%)

  • Sex ‐ male: intervention group: 45 (83%); control group: 49 (96%)


Physically demanding work: white‐collar
Severity of CHD: unknown
Interventions Intervention characteristics

  • Combined cardiac rehabilitation based on social cognitive theory

    • 2 personal bedside education sessions with cardiac nurse

      1. pre‐PCI (45 min): information regarding the procedure and

      2. post‐PCI (60 min): pathology and risk factors for CHD, wound and medication management

    • Individualised goals and plans based on personal risk‐factor profile and educational material based on preferred learning style (assessed with Hill’s Cognitive Style Inventory)

    • Individualised exercise plan (“moderate‐intensity walking programme with a graded increase in the frequency and duration of exercise”)

    • 3 clinician home visits within 2 months post‐PCI:

      • knowledge about CHD reinforced

      • participants' spouses included

      • encouraged exercise and diet monitoring

      • consultation regarding risk‐factor modification strategies; how to monitor rate of perceived exertion (RPE); walked with participants during each home visit; clinician made monthly telephone calls (discussed problems such as lacking the confidence to return to work)

  • Duration of intervention: not reported

  • Providers: cardiac nurse, clinician, occupational therapist, doctoral student


Control group

  • Usual care:

    • 2 personal bedside education sessions with cardiac nurse: 45 min pre‐PCI (information regarding the procedure) and 60 min post‐PCI (pathology and risk factors for CHD, wound and medication management)

    • 3‐monthly post‐discharge CHD clinician telephone call
Outcomes Proportion at work at < 6 months (short term): 2 months
Proportion at work at 6 months–12 months (medium term): 12 months
Psychological adjustment to illness scale: self‐report (PAIS‐SR)
Identification Sponsorship source: Prince Charles Hospital Private Practice Fund
Country: Australia
Setting: home‐based intervention
Possible conflicts of interest: no information provided
Ethics committee approval: informed written consent was obtained
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants “were randomly assigned to either control (standard care and telephone follow‐up) or intervention (individualized, comprehensive, home‐based, cardiac rehabilitation) groups.”
No further information was provided.
Allocation concealment (selection bias) Unclear risk No method of allocation concealment was reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the study, blinding of participants was not possible
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No blinding reported in data collection
Quote: "Occupational information was obtained from the hospital medical records and from interviews with participants at T1, T2 , and T3. Information obtained at T2 and T3 was collected using telephone interviews and mailed questionnaires."
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Although 15 participants were excluded after recruitment due to complications or due to the need for additional surgical procedures, it is unclear how these cases were distributed among the treatment groups. Presumably, the randomisation resulted in evenly distributed groups of 60 participants each, so the attrition of participants would have been comparable in both treatment arms (9 control and 6 intervention participants).
Selective reporting (reporting bias) Unclear risk Unable to determine, no study protocol available
Other bias Unclear risk None identified