Phillips 2001.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: to reduce the incidence of secondary conditions among people with mobility impairment resulting from spinal cord injury. AIM OF STUDY: the results are presented on health related outcomes of a randomized trial of telehealth interventions to reduce the incidence of secondary conditions among people with mobility impairment resulting from spinal cord injury. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: patients with spinal cord injury were recruited during their initial stay. Any patient from 18 to 60 years of age with a newly acquired spinal cord injury was eligible. All participants were research volunteers; once they agreed to participate they were randomly assigned to 1 of 3 groups. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: new spinal cord injury/age 18‐60/ have telephone/ discharged to the community. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: concomitant diagnosis of brain injury, known active substance abuse, mobility impairment level mild. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C. high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: unclear. METHOD OF CONCEALMENT OF ALLOCATION: not specified. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: kruskall‐wallis test. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: neurological patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: unclear. RANDOMISED TO INTERVENTION: 36. RANDOMISED TO CONTROL: 36 ‐ 39. INCLUDED IN ANALYSIS INTERVENTION GROUP: 36. INCLUDED IN ANALYSIS CONTROL GROUP: 36 ‐ 39. AGE: RANGE OR MEAN (SD): 37 (12). GENDER (% MALE): 77. ETHNICITY: 17% African American. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS:new spinal cord injury. OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: unclear. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 55% married. |
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Interventions | DETAILS OF INTERVENTION: 3 groups: telephone, videophone and standard care. Video and phone groups took part in individual educational rehabilitation sessions with a nurse once a week for 5 weeks, then once every 2 weeks for one month. These sessions were in addition to any other regularly scheduled care, such as the two month post discharge care. The content and structure of the education sessions for the phone and video group were similar, except that the video group also saw real time images of the nurse. The intervention sessions lasted a total of nine weeks. DETAILS OF CONTROL: 2 groups: video group and standard care. The standard care group were offered the routine care, which requires patients to call the hospital help line if and when they need assistance prior to the regular 2 months post discharge visit. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION: Frequency: 7. First time at day 7 after discharge. Period: 9 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear. |
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Outcomes | NUMBER OF OUTCOMES: 4 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): Quality of life / quality of well‐being scale (self‐developed??) / unclear / interview / 5 and 9 weeks after discharge. Depression / Center for epidemiologic studies depression scale (self‐developed?) / unclear / interview / 9 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / unclear / unclear / unclear / at 1 year (not included therefore in review data‐analysis). |
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Notes | ·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |